Post on 29-Jan-2023
School of Pharmacy
Development and Evaluation of a Pharmacist Diabetes Management
Tool: A Mixed Method Study
Shamala Ayadurai
This thesis is presented for the Degree of
Doctor of Philosophy
of
Curtin University
September 2017
i
DECLARATION
To the best of my knowledge and belief this thesis contains no material previously
published by any other person except where due acknowledgment has been made.
This thesis contains no material which has been accepted for the award of any other
degree or diploma in any university.
Human Ethics
The research presented and reported in this thesis was conducted in accordance with
the National Health and Medical Research Council National Statement on Ethical
Conduct in Human Research (2007) – updated March 2014. The proposed research
study received human research ethics approvals from the Curtin University Human
Research Ethics Committee (EC00262), Approval Numbers as follows:
1. PH-18-14 for Phase One
2. RDHS-06-14 for Phase Two
3. HR214/2015 for Phase Three
Signature:
Date: 29th September 2017
ii
PUBLICATIONS AND PRESENTATIONS
Publications arising from work in this thesis
1. Ayadurai, S., Hattingh HL, Tee LBG, Md Said SN (2016). A Narrative Review of
Diabetes Intervention Studies to Explore Diabetes Care Opportunities for
Pharmacists. Journal of Diabetes Research 2016: 11. A link to the paper is at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4877480/
2. Ayadurai S, Sunderland VB, Tee LB, Hattingh HL. Consensus Validation of
Simpler: A Tool to Improve Pharmacist Delivery of Quality, Evidence-Based
Diabetes Care. Curr Diabetes Rev 2017. A link to the paper is at
https://www.ncbi.nlm.nih.gov/pubmed/29243582
Presentations arising from work in this thesis
1. Development and validation of Simpler™. Presentation at 2015 Mark Liveris
Health Sciences Research Student Seminar, Curtin University, Perth,
Australia, 3-6 September 2015.
2. Simpler™: an evidence-based pharmacist intervention tool to deliver quality
diabetes care. Oral presentation at 12th Annual National Conference of the
Australian Disease Management Association (ADMA), Melbourne, Australia,
October 20-21, 2016.
3. Evaluation of Simpler™: an evidence-based pharmacist diabetes intervention
tool. Poster presentation at Annual Conference of Australasian
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Pharmaceutical Science Association (APSA), Sydney, Australia, 2-5 December
2016.
4. Effect of the Simpler™ intervention tool in the management of Type 2
diabetes patients: a randomised controlled trial. Poster presentation at
Diabetes Asia conference in Kuala Lumpur, Malaysia, October 12-15, 2017.
5. Simpler™ diabetes interventions: A structured tool to assist pharmacists in
the management of Type 2 diabetes patients. Oral presentation at Diabetes
Asia conference in Kuala Lumpur, Malaysia, October 12-15, 2017.
6. Improving outcomes in Type 2 diabetes patients using a pharmacist diabetes
intervention tool. Poster presentation at APSA-ASCEPT joint scientific
meeting in Brisbane, Australia, December 5-8, 2017.
Grants and awards
1. Received Scott Kimpton, Curtin University Postgraduate Students Association
(CUPSA) Grant in 2016 for undertaking fieldwork research in a developing
country for $1500.
2. Awarded 2nd prize for best oral presentation. Title of presentation: Simpler™
diabetes interventions: A structured tool to assist pharmacists in the
management of Type 2 diabetes patients at Diabetes Asia conference in Kuala
Lumpur, Malaysia, October 12-15, 2017.
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ACKNOWLEDGEMENTS
I would like to thank and acknowledge those who have assisted in the completion of
this thesis. This work would not have been possible without the support of the
Pharmaceutical Services Division, Ministry of Health, Malaysia. I am especially
indebted to Mrs. Rohayah Abd Ghani, Dr. Rooshaimi Merican A Rahim Merican and
Mrs. Rosidah Md Din. I would like to express sincere gratitude to my supervisors,
A/Prof H. Laetitia Hattingh, Emeritus Professor V. Bruce Sunderland, A/Prof Lisa
B.G.Tee and Dr.Siti Norlina Md Said. Each of the supervisors have provided me with
personal and professional guidance and taught me much about research and
scientific writing. I especially like to thank my primary supervisor, Laetitia who agreed
to take on this project, has gone beyond my expectation of a supervisor, and has
provided me with continued motivation and the force needed to strive for the best.
She has given me ample exposure to academic practice. Notably, to be a research
assistant where I had the opportunity to practice my statistical skills and pharmacy
simulation practice where I applied my acting talent. Truly as my supervisor and
mentor she has taught me more than I could ever give her credit here. She has shown
me, by her example what a great lecturer, researcher, supervisor and a person should
be. I would also like to express my sincere gratitude and heartfelt thank you to Bruce
who agreed to take on the project and has given me sufficient guidance and
assistance. I am very grateful to Lisa who has been very supportive and provided the
creative input for this project. My deepest gratitude to Dr.Siti, who has given me
helpful advice during my application for study leave, on all things Perth and her
assistance in this research. A huge thank you to Dr.Richard Parsons for his statistical
advice and Diana Blackwood for her help with literature search and referencing. I
would also like to thank Prof Lynne Emmerton, thesis committee chairman for her
assistance, advice and support. Professor Kevin Batty for approving the funding for
fieldwork and conference presentations. Dr. Tin Fei Sim for her help in Phase Two.
Li Yun Chong for her assistance in pharmacist recruitment for Phases Two and Three.
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A big thank you to all participants in Phases One, Two and Three who have shown
such commitment and enthusiasm throughout the research process. Thank you to
pharmacists in charge; Azlina (Mersing), Rahmah (Tangkak), Azwin (Muar), Ruzia
(Kota Tinggi), Mazni and Siti Khairani (Segamat) for their support throughout the
research process. Thank you to Phase Three pharmacists: Norain Mohd Puat;
Christina Chan; Nurul Huda Yasim; Nur Elyana Yazmin Mohd Shah Edwin; Nur Salwa
Abdul Halim; Chen Kun Ng; Kok Pun Lee; Sharon Augustine Amburose, Nurul Azwa
Ishak; Hui Yng Tan; Sin Wei Tey; Cha Sin Tan; Yoke Kuan Foong and Mohd Azmer Lias.
Nobody has been more important to me in the pursuit of this research than my
mother, Mrs T.Ayadurai, who has always challenged me to attain the highest
recognition in the ongoing quest for knowledge. My sister Charmele who is my
inspiration and is a constant amazement. My late father, Mr.A.M Ayadurai who had
always wanted me to be a doctor. My late grandmother, Madam Sundram who
showed me what courage and determination meant. My uncle, Mr.Thangaraju who
had constantly shared his wisdom.
I would also like to express my gratitude to Norman Johnson, Amanda Tan, Yen Hieu
and Adam Stapley who gave me the opportunity to serve the KV community and
provided me with the comfort of home away from my home. I would like to thank all
my flatmates past and present and my friends who have been there to support me.
Thank you, Amelia K, Annette Z, Aminath, Asmida, Ausana, Chew Beng, Christofori,
Dee J, Fatch K, Hasni H, Hendra, Jerry W, Josephine L, Khanh D, Kenneth L, Kevin A,
Kim Ye, Linda K, Maegan C, Mazin K, Mustafa A, Melissa G, Oiyammal C, Pauline E,
Petra C, Razian, Sangeetha M, Satoko M, Tammy R, Thanh T, and countless others
who have been an inspiration and helped me one way or another.
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This thesis is dedicated to every pharmacist, the pharmacy profession and to Jimmy
for teaching me what I needed to know.
vii
THESIS ABSTRACT
Introduction/Background: Pharmacists’ contributions towards improving clinical
outcomes of patients with diabetes are well documented. However, strategies used
to deliver quality diabetes care are inconsistent. This research aimed to 1) develop
and validate a structured pharmacist type 2 diabetes (T2DM) intervention tool,
referred to as the Simpler™ tool; 2) explore the impact of targeted training addressing
pharmacists’ knowledge and ability to deliver evidence-based diabetes care and 3)
determine the effectiveness of a multifactorial evidence-based diabetes intervention
tool among T2DM patients.
Method: There were three phases for this research. In Phase One, the Delphi method
was used to validate the Simpler™ tool by obtaining consensus from 12 diabetes
experts from Australia and Malaysia. The experts consisted of endocrinologists from
the community, hospital, pharmacy administration and academic practice, general
practitioners, diabetes nurse, family medicine specialist and public health physician
who was also the contributing author for the 2015 Malaysian diabetes guideline. In
Phase Two, the Simpler™ training package was developed to train 12 pharmacists
from community practice without formal diabetes training from Australia and
Malaysia on diabetes management. Pharmacists’ knowledge was assessed pre-and
post-training and they were required to use the tool in practice for a one-month
period. Subsequently, perception on the feasibility of the tool was obtained through
semi-structured interviews. Participant feedback on the tool were applied to refine
the tool and the training package. Phase Three consisted of a 6-month, parallel,
randomised controlled trial (RCT) conducted in seven primary health clinics in Johor,
Malaysia. Fourteen pharmacists were trained using the Simpler™ training package
developed and validated in Phase Two. Pharmacists without formal diabetes training
and with less than three years of providing diabetes management service were
recruited. In Phase Three, the effectiveness of the tool was measured through the
number of Simpler™ interventions conducted by pharmacists. Additionally, the
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impact of the tool on the clinical outcomes such as glycated haemoglobin (HbA1c),
blood glucose, blood pressure and lipid levels; changes to medication adherence,
physical activity, waist circumference and body mass index was analysed.
Consequently, the overall impact on patient’s health related quality of life was
assessed pre-and post-intervention for both arms.
Results: In Phase One, the Simpler™ indicators were categorised into seven broad
treatment areas referred to as the seven diabetes factors presented in the figure
below and are as follows:
1. the use of statin/lipid-regulation medicine
2. the use of insulin and glycaemic control
3. medication adherence and addressing medication-related problems (MRP)
4. addressing BP control
5. addressing lifestyle issues
6. providing education and
7. reducing CVD risk
Figure: The seven diabetes factors in type 2 diabetes management
Diabetes Management
SStatin/
cholesterol IInsulin/
Glycaemic
MMedication
PBlood
Pressure
LLifestyle
EEducation
RCVD Risk
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Of the 38 indicators presented to the panel, 36 (94.7%) achieved consensus level at
60% after a three round Delphi method. In Phase Two, pre-and post-training
assessments showed significantly improved test scores (p=0.002). The median pre-
test score was 6.5/27, IqR 1.4 (first assessor) and 5.3/27, IqR 2.0 (second assessor).
The full marks being 27 marks. After attending the training program, the scores
improved to 14.3/27, IqR 4.5 (first assessor) and 11.3/27, IqR 3.1 (second assessor).
Interview analysis on the Simpler™ training revealed that the facilitating factors were
1) structured medication reviews, 2) improved knowledge and record keeping, 3)
increased ability to detect problems in uncontrolled patients with diabetes and 4)
focused on achieving diabetes targets. Five topics emerged from the interview
regarding the tool. Those were:
1. it facilitated pharmacists’ role,
2. it was specific for diabetes management,
3. it had wider usage,
4. it presented a competitive edge, and
5. it targeted glycaemic improvement
Participants’ suggestions for improvements to the training modules were to:
1. include a template to record pharmacist’s interventions,
2. retrieve patient’s data first before application of the Simpler™ tool,
3. add more information on glucagon administration, MRPs, diet and lifestyle,
and
4. include health information such as leaflets for patients
Improvements for the Simpler™ tool hand-out included:
1. visual prompts,
2. larger font for headings,
3. medication adherence assessment tool and plate model in the tool,
4. two versions of the tool to incorporate each country’s (Australia and
Malaysia) individual treatment goals,
5. Asian and Caucasian terms to differentiate the body mass index targets.
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All suggestions were taken into consideration and subsequent improvements were
made to the training modules content and to the tool.
Phase Three RCT recruited 77 patients in each arm. Of these, 49 intervention patients
and 63 usual care patients were assessable for HbA1c measurement. The HbA1c
levels significantly improved in the intervention arm; mean reduction of 1.59%
(95%CI: -2.2, -0.9) compared with reduction of 0.25% (95%CI: -0.62, 0.11) in the usual
care arm (n=63), (p=<0.001). In addition, there were significant improvements in
systolic blood pressure: [-6.28 mmHg (95%CI: -10.5, 2.0), p=0.005] and health related
quality of life [-1.75, (95%CI: -2.52, -0.97), p<0.001]. A total of 66 recommendations
were made to prescribers and 51 interventions were predicated with doctors using
the Simpler™ tool. The most common MRPs were patients’ non-adherence (n=135,
44.9%) followed by sub therapeutic dosage (n=65, 21.6%) and needed additional
therapy (n=52, 17.3%). The most frequent causes of non-adherence to medications
was patients ‘forget to take’ (n=124, 68.1%) and ‘prefers not to take’ (n=42, 23.1%).
A majority of pharmacist interventions included medication reminder chart (n=39,
59.1%) followed by reinitiating drug therapy (n=21, 31.8%). Pharmacists worked in
collaboration with doctors to add medications (n=23, 45.1%) and change dosages
(n=17, 33.3%).
Conclusions: Training involving the use of the Simpler™ tool developed by a
structured process improved pharmacists’ knowledge on diabetes management,
facilitated delivery of evidence-based, individualised diabetes care, and consequently
improved clinical and quality of life outcomes. It also provided an effective support
for pharmacists with limited clinical experience in diabetes care to enhance quality
of care provided.
xi
ABBREVIATIONS
ACCORD Action to control cardiovascular risk in diabetes trial
ACEI Angiotensin converting enzyme inhibitor
ADDITION-Europe Anglo-Danish-Dutch study of intensive treatment in people with
screen detected diabetes in primary care
ADVANCE Action in diabetes and vascular disease: preterax and diamicron MR
controlled evaluation trial
ARB Angiotensin receptor blocker
BGL Blood glucose level
BMI Body mass index
CONSORT Consolidated standards for reporting trials.
CPG Clinical practice guidelines
CDTM Collaborative drug therapy management
CVD Cardiovascular disease
DCCT Diabetes control and complications trial
DESMOND Diabetes education and self-management for ongoing and newly
diagnosed for people with type 2 diabetes
DMAS Diabetes medication assistance service
DPP-4 inhibitor Dipeptidyl peptidase-4 inhibitor
ELIXA Evaluation of lixisenatide in acute coronary syndrome trial
EMPA-REG
OUTCOME
Empagliflozin-cardiovascular outcomes and mortality in type 2
diabetes trial
EXAMINE Cardiovascular outcomes study of alogliptin in patients with type 2
diabetes and acute coronary syndrome
8-items MMMAS Eight items modified Morisky medication adherence
FBG Fasting blood glucose
FRS Framingham risk score
GLP-1 agonist Glucagon-like peptide-1 receptor agonist
GPs General practitioners
HbA1c Glycated haemoglobin
HCP Healthcare professionals
KK Klinik kesihatan,
LDL Low density lipoprotein
xii
LEADER Liraglutide effect and action in diabetes: evaluation of
cardiovascular outcome results trial
Look AHEAD Look action for health in diabetes trial
MMS Medication management service
MRP Medication-related problem
NCD Non-communicable disease
NICE National Institute for Health and Care Excellence
OHA Oral hypoglycaemic agents
PCC Patient centred care
PDE-5 inhibitor Phosphodiesterase-5 inhibitor
PMR Patient medical record
PPG Post prandial blood glucose
PROactive Prospective pioglitazone clinical trial in macrovascular events
QOL Quality of Life
RBG Random blood glucose
RCT Randomised controlled trial
RECORD Rosiglitazone evaluated for cardiac outcomes and regulation of
glycaemia in diabetes
SAVOR-TIMI 53 Saxagliptin assessment of vascular outcomes recorded in patients
with diabetes mellitus
SC Simpler™ care
SCR Summary care record
SD Standard deviation
SGLT-2 Sodium-glucose cotransporter-2
SMBG Self-monitoring of blood glucose
SUSTAIN-6 Trial to evaluate cardiovascular and other long-term outcomes with
semaglutide in subjects with type 2 diabetes
T2DM Type 2 diabetes mellitus
TECOS Trial to evaluate cardiovascular outcomes after treatment with
sitagliptin
TG Triglyceride
UC Usual care
UK United Kingdom
xiii
UKPDS United Kingdom prospective diabetes study
USA United States of America
VADT Veterans affairs diabetes trial
xiv
DEFINITIONS
8-items
MMMAS
This is a modified version of the Morisky medication adherence scale,
which consists of eight questions.(1)
ACEI Class of drugs that inhibit angiotensin-converting enzyme, which
converts angiotensin 1 to angiotensin 2. Angiotensin 2 increases
aldosterone synthesis and raises blood pressure through
vasoconstriction.(2)
ARB Class of drugs which blocks Angiotensin 1 receptor which reduces the
effect of angiotensin 2 and subsequently reduces blood pressure.(2)
CONSORT Consists of a checklist and a flow diagram which provides guidelines for
authors to report the findings from randomised controlled trials.(3)
Diabetes
MedsCheck
Diabetes medication management service provided by community
pharmacy in Australia. This service includes a review of consumer’s
medications focusing on self-education and self-management. The
program is funded under the fifth and sixth community pharmacy
agreement under the Department of Health and Ageing.(4)
Education
levels
In Malaysia, primary education starts at age seven to age 12. Secondary
education begins at age 13 and ends at age 17. Pre-university/diploma
courses are offered to students who have completed secondary
education.
Ethnic
Chinese
Refers to population from China who migrated to Malaysia in the 3rd and
19th century. (5)
Ethnic Indian Refers to population from India, Sri Lanka, Pakistan and Bangladesh who
migrated to Malaysia in the 3rd and 19th century.(5)
FBG Blood glucose level taken in the morning before meals. Malaysian
guideline recommends 4.4-7.0 mmol/L while Australia recommends 6-8
mmol/L.(6, 7)
FRS Risk assessment tool used to predict patient’s 10 year risk of developing
cardiovascular disease.(8)
HbA1c HbA1c is glycated haemoglobin. As HbA1c remains in blood circulation
for 3 months, the amount of HbA1c present, expressed, as a percentage
of haemoglobin A, is proportional to the glucose concentration over that
time.(6) All HbA1c units in thesis report both % and mmol/ml. However,
xv
the conversion rate of HbA1c units from DCCT (%) to IFCC (mmol/mol)
only allows from 4% to 24%. Therefore, HbA1c units below 4% are
reported in % only.
KK Primary health care clinics which are public funded, government
managed institutions. Malaysian citizens pay a subsidised amount of
RM1 (USD 0.23) for doctor’s consultation and medicine cost for each
visit.
Melayu Also known as Malay. Refers to an ethnic in Malaysia whose origin dates
to Indian, Chinese, Thai, Portuguese, Cambodian and Indonesian
heritage(304) and includes indigenous population in Malaysia.(9)
MTAC
Diabetes
Diabetes medication management service provided by pharmacists in
government health institutions in Malaysia with no added cost to
patients. The service includes a review of consumer’s medicines focusing
on clinical interventions, self-education, self-management and patient
follow up for a maximum for eight visits.(10)
OHA Drugs that are administered orally to treat Type 2 diabetes mellitus. They
reduce elevated blood glucose.(6)
PPG Blood glucose level taken two hours after meals. The recommended
level according to Malaysian guidelines are 4.4-8.5 while Australian
guidelines recommend 8-10 mmol/L.(6, 7)
Simpler™ The name of the diabetes intervention tool studied in this research. TM
accompanying the word Simpler stands for the trademark symbol.
WHOQOL-
BREF
World Health Organization Quality of Life Questionnaire is an
abbreviated 26 item questionnaire to assess individuals’ perceptions in
relation to their goals, expectations, standards and concerns.(11)
It consists of four domains namely physical health, psychological, social
relationships and environment. Each of the four domains contains
questions pertaining to facets of the specific domain. The facets are:
1.Physical health: daily activities, work ability, pain, sleep and energy
2.Psychological: body image, self-esteem, thinking and concentration,
feelings
3.Social relationships: personal relationships, social support
xvi
4.Environment: accessibility and quality to health and social care,
opportunities for acquiring new information and skills, participation in
leisure activities
xvii
TABLE OF CONTENTS
PUBLICATIONS AND PRESENTATIONS .......................................................................................ii
ACKNOWLEDGEMENTS ............................................................................................................ iv
THESIS ABSTRACT .................................................................................................................... vii
ABBREVIATIONS ....................................................................................................................... xi
DEFINITIONS ........................................................................................................................... xiv
TABLE OF CONTENTS ............................................................................................................. xvii
LIST OF TABLES ..................................................................................................................... xxiii
LIST OF FIGURES ................................................................................................................... xxvi
Chapter 1 Introduction............................................................................................................ 0
1.1 Introduction ...................................................................................................................1
1.1.1 Type 2 diabetes mellitus .................................................................................... 1
1.1.2 Pharmacological treatment of T2DM ................................................................. 3
1.1.3 Role of pharmacists in diabetes management ................................................... 4
1.2 Overview of research .....................................................................................................5
1.3 Research questions ........................................................................................................9
Chapter 2 A Review of Literature .......................................................................................... 10
2.1 Introduction ................................................................................................................ 11
2.1.1 Prevalence of diabetes and its complications ....................................................... 11
2.1.2 Evidence-based diabetes care............................................................................... 12
2.1.3 Pathophysiology of T2DM ................................................................................ 17
2.1.4 Pharmacological treatment of T2DM ............................................................... 18
2.2 Multifactorial intervention .............................................................................................. 24
2.2.1 Cholesterol control ........................................................................................... 25
2.2.2 Glycaemic control ............................................................................................. 26
2.2.3 Medication management ................................................................................. 27
2.2.4 Blood pressure (BP) control ............................................................................. 29
2.2.5 Lifestyle management ...................................................................................... 30
2.2.6 Education provision .......................................................................................... 31
2.2.7 CVD risk management ...................................................................................... 32
2.2.8 Effectiveness of multifactorial interventions ................................................... 32
2.3 Patient centred care (PCC) .......................................................................................... 46
xviii
2.3.1 Role of pharmacists in diabetes management ................................................. 46
2.3.2 Pharmacist-provided medication management service (MMS) ...................... 48
2.3.3 Australian provided diabetes MMS: Diabetes MedsCheck .............................. 48
2.3.4 Malaysian provided diabetes MMS: MTAC diabetes ....................................... 49
2.4 Diabetes intervention strategy for pharmacists ......................................................... 49
2.4.1 Requirement for targeted training program .................................................... 50
2.4.2 Pharmacist access to patient medical records (PMR) ...................................... 51
2.4.3 Diabetes intervention tool ............................................................................... 52
2.5 Overall thesis research area ........................................................................................ 55
Chapter 3 Development and Validation of the Tool .............................................................. 56
3.1 Introduction ................................................................................................................ 57
3.1.1 The Delphi process ........................................................................................... 57
3.1.2 Advantages of using the Delphi process .......................................................... 58
3.2 Objectives .................................................................................................................... 61
3.3 Method ........................................................................................................................ 61
3.3.1 Ethical approval ................................................................................................ 62
3.3.2 Recruitment of participants ............................................................................. 62
3.3.3 Development of Simpler™................................................................................ 63
3.3.4 Development of the Delphi questionnaire....................................................... 65
3.3.5 The Delphi rounds ............................................................................................ 79
3.3.6 Duration of the Delphi rounds ......................................................................... 81
3.3.7 Achieving consensus ........................................................................................ 82
3.3.8 Stability of the rounds ...................................................................................... 83
3.4 Results ......................................................................................................................... 84
3.4.1 Participants ...................................................................................................... 84
3.4.2 Delphi round 1 .................................................................................................. 85
3.4.3 Delphi round 2 .................................................................................................. 91
3.4.4 Delphi round 3 .................................................................................................. 93
3.5 Discussion .................................................................................................................. 102
3.5.1 Cholesterol control ......................................................................................... 103
3.5.2 Insulin/glycaemic control ............................................................................... 103
3.5.3 Medication management ............................................................................... 104
3.5.4 BP control ....................................................................................................... 105
3.5.5 Lifestyle .......................................................................................................... 105
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3.5.6 Education........................................................................................................ 107
3.5.7 CVD risk factors .............................................................................................. 108
3.5.8 Strengths of Phase One .................................................................................. 109
3.5.9 Limitations of Phase One ............................................................................... 111
3.5.10 The next stage ............................................................................................ 112
Chapter 4 Pharmacists’ Experience and Perceptions on Using the Simpler™ Tool ............ 113
4.1 Introduction .............................................................................................................. 114
4.1.1 Credentialed diabetes pharmacist ................................................................. 115
4.1.2 Short term diabetes management training program ..................................... 117
4.2 Objectives .................................................................................................................. 118
4.3 Method ...................................................................................................................... 119
4.3.1 Ethics approval ............................................................................................... 119
4.3.2 Study design ................................................................................................... 120
4.3.3 Development of the Simpler™ training package ............................................ 125
4.3.4 Recruitment of participants ........................................................................... 130
4.3.5 Training session evaluations .......................................................................... 132
4.3.6 Semi-structured interviews ............................................................................ 133
4.3.7 Data analysis................................................................................................... 135
4.4 Results ....................................................................................................................... 136
4.4.1 Participant demographic and diabetes practice experience data ................. 136
4.4.2 Training session evaluations .......................................................................... 139
4.4.3 Semi-structured interviews ............................................................................ 141
4.4.4 Modifications to the Simpler™ tool ............................................................... 159
4.5 Discussion .................................................................................................................. 165
4.5.1 Participant demographic and diabetes practice experience ......................... 165
4.5.2 Perceived effectiveness of the Simpler™ tool ................................................ 166
4.5.3 Positive aspects of training sessions .............................................................. 167
4.5.4 Overall implications of the Simpler™ tool ...................................................... 168
4.5.5 Barriers and challenges using the Simpler™ tool ........................................... 170
4.5.6 Limitations and suggestions for future work ................................................. 171
4.6 Conclusion ................................................................................................................. 173
Chapter 5 Impact of the Simpler™ Multifactorial Diabetes Intervention on Type 2 Diabetes
Patients in Johor, Malaysia: A Randomised Controlled Trial ............................................... 174
5.1 Introduction .............................................................................................................. 175
xx
5.1.1 Malaysian healthcare system ......................................................................... 176
5.1.2 Determinants of glycaemia improvement ..................................................... 178
5.1.3 Diabetes management among Muslim patients ............................................ 184
5.1.4 The state of Johor, Malaysia .......................................................................... 185
5.2 Objectives .................................................................................................................. 186
5.3 Methods .................................................................................................................... 187
5.3.1 Recruitment process ...................................................................................... 190
5.3.2 Data collection ............................................................................................... 200
5.3.3 Data analysis................................................................................................... 200
5.4 Results ....................................................................................................................... 201
5.4.1 Demographic characteristics of pharmacists ................................................. 201
5.4.2 Results from pre-and post-training questionnaire ........................................ 204
5.4.3 Demographic characteristics of patients ....................................................... 205
5.4.4 Medication use at baseline and changes at six months ................................. 211
5.4.5 Doctor’s visits and hospital admissions at 6 months ..................................... 215
5.4.6 Pharmacists’ interventions ............................................................................. 215
5.4.7 Clinical outcomes of patients in both arms .................................................... 220
5.4.8 Comparison of QOL outcomes between the Simpler™ care and usual care . 236
5.4.9 Analysis of patient case studies ..................................................................... 242
5.5 Discussion .................................................................................................................. 249
5.5.1 Patients’ clinical outcomes based on the Simpler™ tool indicators .............. 250
5.5.2 Quality of life outcomes ................................................................................. 259
5.5.3 Strengths of Phase Three study ..................................................................... 262
5.5.4 Limitations ...................................................................................................... 264
5.6 Conclusions ............................................................................................................... 266
Chapter 6 General Discussion and Conclusions ................................................................... 267
6.1 General discussion .................................................................................................... 268
6.2 Conclusions ............................................................................................................... 275
6.3 Future directions ....................................................................................................... 276
References ........................................................................................................................... 278
Appendices ........................................................................................................................... 302
Appendix 3. 1: Phase One ethics approval ................................................................... 303
Appendix 3. 2: Phase One participant information sheet............................................ 304
Appendix 3. 3: Introductory letter to Phase One participants .................................... 305
xxi
Appendix 3. 4: Round 1 questionnaire......................................................................... 306
Appendix 3. 5: Excerpt from Round 2 Questionnaire .................................................. 312
Appendix 3. 6: Excerpt of SPSS data set for Phase One data ....................................... 313
Appendix 3. 7: Excerpt from Round 3 questionnaire ................................................... 314
Appendix 4. 1: Phase Two ethics approval (Australia) ................................................. 315
Appendix 4. 2: Phase Two ethics approval (Malaysia) ................................................. 316
Appendix 4. 3: The Simpler™ training modules outline ............................................... 318
Appendix 4. 4: The Simpler™ hand-out version of the slide presentations ................. 319
Appendix 4. 5: The Simpler™ training list of websites ................................................. 332
Appendix 4. 6: The Simpler™ tool hand-out for Phase Two participants .................... 333
Appendix 4. 7: Introductory letter to Phase Two participants .................................... 334
Appendix 4. 8: Phase Two participant information sheet ........................................... 335
Appendix 4. 9: Phase Two consent form ..................................................................... 337
Appendix 4. 10: Pre-and post training questionnaire .................................................. 338
Appendix 4. 11: Marking scheme for pre-and post training questionnaire (trial version)
..................................................................................................................................... 344
Appendix 4. 12: Marking scheme for pre and post training questionnaire (revised) .. 346
Appendix 4. 13: Interview guide .................................................................................. 349
Appendix 4. 14: Hand-out version of additional slide presentations (revised) ........... 351
Appendix 5. 1: Phase Three ethics approval (Australia) .............................................. 354
Appendix 5. 2: Phase Three ethics approval (Malaysia) .............................................. 355
Appendix 5. 3:Phase Three ethics renewal (Malaysia) ................................................ 357
Appendix 5. 4: User agreement for WHOQOL-BREF .................................................... 358
Appendix 5. 5: Phase Three pharmacist information sheet (pharmacist) ................... 361
Appendix 5. 6: Phase Three pharmacist consent form ................................................ 363
Appendix 5. 7: Application for conducting research to director of Johor State Health
Department .................................................................................................................. 364
Appendix 5. 8: Letter to the manager of each clinic (KK) ............................................ 366
Appendix 5. 9: Letter of approval to conduct research at the seven districts in Johor 367
Appendix 5. 10: Agenda for Phase Three RCT briefing ................................................ 368
Appendix 5. 11: The Simpler™ Pro forma A ................................................................. 369
Appendix 5. 12: The Simpler™ Pro forma B ................................................................. 373
Appendix 5. 13: WHOQOL-BREF questionnaire (Bahasa Malaysia) ............................. 376
Appendix 5. 14: WHOQOL-BREF questionnaire (English) ............................................ 378
xxii
Appendix 5. 15: WHOQOL-BREF questionnaire (Mandarin) ........................................ 380
Appendix 5. 16: Phase Three participant information sheet (English) ........................ 383
Appendix 5. 17: Phase Three consent form for patients (English) .............................. 385
Appendix 5. 18: Phase Three participant information sheet (Bahasa Malaysia) ......... 387
Appendix 5. 19: Phase Three participant consent form (Bahasa Malaysia) ................ 389
Appendix 5. 20: 8- items modified Morisky medication adherence scale (English) .... 391
Appendix 5. 21: 8-items modified Morisky medication adherence scale (Bahasa
Malaysia) ...................................................................................................................... 392
Appendix 5. 22: Naranjo adverse drug reaction probability scale ............................... 393
Appendix 5. 23: Data collection form .......................................................................... 394
Appendix 5. 24: Simpler™ tool hand-out for Phase Three pharmacists ...................... 397
Appendix 5. 25: Excerpt of SPSS data set for Phase Three data .................................. 399
Appendix 5. 26: Baseline characteristics of patients who completed two visits ......... 400
xxiii
LIST OF TABLES
Table 2.1: Landmark diabetes trials ....................................................................................... 14
Table 2.2: Pharmacotherapy of diabetes medications and its related trials on CVD risk
reduction outcome ................................................................................................................. 20
Table 2.3: Types of diabetes intervention studies conducted by healthcare professionals
besides pharmacists ............................................................................................................... 35
Table 2.4: Types of pharmacist led diabetes intervention studies ......................................... 39
Table 2.5: Evidence-based intervention tools ........................................................................ 52
Table 3.1: Intervention studies using the Delphi process ....................................................... 59
Table 3.2: Reference justification for each indicator of Part 1 questionnaire ....................... 66
Table 3.3: Part 1 questionnaire instructions .......................................................................... 75
Table 3.4: Reference justification for seven indicators in Part 2 of the questionnaire .......... 78
Table 3.5: Breakdown of Delphi process participants (n=13) ................................................ 85
Table 3.6: Indicators which participants missed answering .................................................. 86
Table 3.7: Results of Round 1 Part 1 ...................................................................................... 87
Table 3.8: Results of Round 1 Part 2 ...................................................................................... 89
Table 3.9: Results of Round 2 Part 1 ...................................................................................... 91
Table 3.10: Results of Round 2 Part 2 .................................................................................... 93
Table 3.11: Results of Round 3 Part 1 .................................................................................... 94
Table 3.12: Results of Round 3 Part 2 .................................................................................... 99
Table 3.13: The order of appearance of indicators in Simpler™ hand-out based on outcomes
from the Delphi interview .................................................................................................... 100
Table 3.14: Response rate from participants and number of indicators that achieved
consensus ............................................................................................................................. 110
Table 4.1: Simpler™ modules contents and goals ................................................................ 127
Table 4.2: Australian and Malaysian participant demographics and practice information 137
Table 4.3: Statistical representation of participant demographic and practice information
............................................................................................................................................. 138
Table 4.4: Pre- and post-training scores of participants (n=12) .......................................... 141
xxiv
Table 4.5: Types of interventions made by pharmacists using the Simpler™ tool ............... 146
Table 4.6: Barriers and challenges in using Simpler ............................................................. 159
Table 4.7: Revised Simpler™ tool hand-out (Malaysian version) ......................................... 161
Table 4.8: Revised Simpler™ tool hand-out (Australian version) ......................................... 163
Table 5.1: Diabetes intervention studies conducted by pharmacists in Malaysia ............... 179
Table 5.2: Simpler™ tool resource pack contents ................................................................ 197
Table 5.3: Primary and secondary outcome variables measured at baseline and for the
subsequent six months ......................................................................................................... 199
Table 5.4: Participating pharmacists practice experience (years) ....................................... 203
Table 5 5: Pharmacists pre- and post-training scores of participants (n=14) ...................... 205
Table 5.6: Number of patients recruited and number of dropouts from each KK ............... 206
Table 5.7: Breakdown of SC patients who completed the three to six visits with the
pharmacist ........................................................................................................................... 208
Table 5.8: Baseline characteristics of the study population................................................. 210
Table 5.9: Medication use and changes over six months in SC and UC arms ...................... 212
Table 5.10: Other medication used by patients in both SC and UC arms ............................ 214
Table 5.11: Simpler™ interventions conducted on SC patients over the 6 months follow up
............................................................................................................................................. 217
Table 5.12: Clinical parameters of participants at baseline and on 6 months follow up in SC
and UC arms ......................................................................................................................... 221
Table 5.13: Comparison of participants in SC and UC arms who met treatment target at 6
months according to the 2015 Malaysian clinical practice guidelines on of T2DM.(6) ....... 222
Table 5.14: Comparison of patients who achieved a mean reduction of 1% HbA1c between
arms ..................................................................................................................................... 225
Table 5.15: Changes in blood glucose parameters at baseline and at 6 months follow up in
both arms ............................................................................................................................. 227
Table 5.16: 8-item MMMAS responses at baseline and at 6 months in SC arm (n=55) ....... 229
Table 5.17: Number of medicine related problems identified by pharmacists for SC arm over
6 months .............................................................................................................................. 231
Table 5.18: Number of pharmacist collaborations with SC patients and doctors ............... 232
Table 5.19: Types of education provided to patients in the SC arm ..................................... 235
xxv
Table 5.20: Changes in WHOQOL-BREF domain scores between both arms from baseline to 6
months follow-up [scores transformed from 4-20 according to WHOQOL-BREF manual.(11)]
............................................................................................................................................. 237
Table 5.21: Changes in WHOQOL-BREF domain scores between both arms from baseline to 6
months follow-up [scores transformed from 0-100 according to WHOQOL-BREF
manual.(11)] ........................................................................................................................ 238
Table 5.22: Impact of patients’ characteristics on overall WHOQOL-BREF score ................ 241
xxvi
LIST OF FIGURES
Figure 1.1: Overall thesis outline .............................................................................................. 7
Figure 2.1: The multiple factors involved in providing diabetes care management .............. 25
Figure 3.1: The Simpler acronym derived from letters in the seven diabetes factors ............ 64
Figure 3.2: Order of appearance in hand-out ........................................................................ 75
Figure 3.3: Hand-out of the Simpler™ tool (Bookmark design).............................................. 77
Figure 3.4: Hand-out of the Simpler™ tool (Wheel design) .................................................... 77
Figure 3.5: Flow of the Delphi process ................................................................................... 82
Figure 3.6: Clarification of allocation of numbers for indicator 9 under glycaemic
control/insulin factors ............................................................................................................ 97
Figure 3.7: Clarification of allocation of numbers for indicator 19 under lifestyle factors .... 98
Figure 4.1: Phase 2 research workflow ................................................................................ 124
Figure 4.2: Flow chart summarises the flow of the Simpler™ tool training process ............ 129
Figure 4.3: Overview of training modules uploaded into the cloud service. ........................ 130
Figure 4.4: Length of years conducting diabetes MedsCheck or MTAC Diabetes ................ 138
Figure 4.5: Breakdown of factors that motivated pharmacists to participate in the research
............................................................................................................................................. 140
Figure 4.6: Pharmacy practice differences between Australian and Malaysian pharmacists
............................................................................................................................................. 142
Figure 4.7: Participant referral frequency to Australian or Malaysian diabetes practice
guideline ............................................................................................................................... 143
Figure 4.8: Training session facilitators ............................................................................... 150
Figure 4.9: Recommendations to improve future training sessions..................................... 151
Figure 4.10: Participants’ suggestions for improvement to the Simpler™ tool ................... 152
Figure 4.11: Five topics that emerged from the analysis ..................................................... 153
Figure 4.12: Facilitators of the Simpler™ tool ...................................................................... 157
Figure 5.1: Location of the ten districts in the state of Johor............................................... 186
xxvii
Figure 5.2: Flow diagram of the Phase Three research protocol ......................................... 189
Figure 5.3: Flow diagram of the process involved in the intervention and control arms ..... 194
Figure 5.4: Location of participating sites in the state of Johor, Malaysia using Google
maps.(339) ........................................................................................................................... 202
Figure 5.5: Factors that motivated pharmacists to participate in Phase Three research .... 204
Figure 5.6: CONSORT diagram of patients’ recruitment and completion. ........................... 207
Figure 5.7: Comparison of patients’ visits to the doctor for SC and UC arms ...................... 215
Figure 5.8: Standard error of mean HbA1c difference levels between baseline and 6 months
for both arms ....................................................................................................................... 224
Figure 5.9: Median fasting blood glucose (FBG) in the SC arm during each visit to the
pharmacy ............................................................................................................................. 227
Figure 5.10: Changes in adherence scores in the SC arm according to 8-item MMMAS tool
............................................................................................................................................. 228
Figure 5. 11: Comparison between mean FBG and mean systolic BP between each visit ... 233
Figure 5.12: Comparison of 8-item MMMAS scores, blood glucose levels and systolic BP at
each visit for patient ID 417 ................................................................................................. 244
Figure 5.13: Comparison of 8-item MMMAS scores, blood glucose levels and systolic BP at
each visit for patient ID 416 ................................................................................................. 246
Figure 5.14: Comparison of 8-item MMMAS scores, blood glucose levels and systolic BP at
each visit for patient ID 508 ................................................................................................. 249
1
1.1 Introduction
Community pharmacists are easily accessed by patients, are increasingly seen as
medicine experts and are expected to address clinical issues in patients with chronic
diseases such as diabetes.(12) However, little is known of the processes followed by
pharmacists to retrieve information and make pharmaceutical care
interventions.(13) Hence, most diabetes studies evaluating pharmacists’
intervention have reported varied clinical outcomes, ranging between some
improvements to minimal difference.(14) Diabetes is a chronic condition with
prevalence of diabetes continuing to rise, and hence there is an urgent need for a
targeted and structured approach to diabetes care in order to prevent diabetes
related complications such as CVD, nephropathy and neuropathy.
Diabetes Mellitus is a condition where there is lack of insulin to regulate the blood
sugar level or when existing insulin is not utilised efficiently. The World Health
Organization (WHO) classifies diabetes mellitus into Type 1 diabetes mellitus, Type 2
diabetes mellitus (T2DM) and Gestational diabetes.(15) Type 1 was formerly known
as insulin-dependent, juvenile or childhood onset. Patients with Type 1 diabetes
need insulin replacement as they are insulin deficient. T2DM used to be known as
non-insulin dependent and is due to inefficient use of existing insulin in the body.
Gestational diabetes occurs at first onset during pregnancy. Although the blood
glucose level (BGL) is above normal in gestational diabetes it is below the level to be
diagnosed as diabetes. This thesis will however only focus on the management of
T2DM.
1.1.1 Type 2 diabetes mellitus
T2DM is typified by hyperglycaemia. The increase in blood glucose is caused by
increased carbohydrate intake, increased synthesis of hepatic glucose, decreased
2
insulin secretion and consequently decreased peripheral glucose uptake. There are
several factors involved in the pathogenesis of diabetes. Insulin resistance is
associated with increase in intraabdominal adipose tissue, decrease in glucokinase
action which increases the conversion of substrates to glucose. In addition, other
factors postulated are a rise in free fatty acid levels which intensifies glucose
production in the liver and enhanced gluconeogenesis process which increases
glucose production in the kidney. The symptoms of T2DM include polyuria,
polydipsia, polyphagia and weight loss, blurred vision and lower-extremity
numbness. Current diabetes guidelines from Australia, Malaysia, the United Kingdom
(UK) and the United States of America (USA) recommend diet and exercise as
treatment and suggests pharmacological intervention if goals of therapy are not
achieved within three months.(6, 7, 16, 17)
The guidelines also recommend glycated haemoglobin (HbA1c) to measure blood
glucose concentrations among patients with diabetes.(6, 7, 16, 17) HbA1c gives an
average measurement of blood glucose levels in the previous three months and
therefore reflects a person’s long term control of the disease. In addition, the
guidelines require persons using insulin to monitor their blood glucose levels daily
using the finger pricking method in order to optimise treatment.
The main aim of T2DM management is to improve clinical outcomes and
subsequently prevent diabetes related complications.(16) Clinical outcomes in
diabetes consists of body mass index (BMI), HbA1c, cholesterol, blood pressure,
fasting blood glucose (FBG) and post prandial glucose (PPG). These outcomes are
reported as therapeutic targets required to be achieved according to evidence-based
practice. Often the therapeutic targets need to be individualised depending on the
person’s age, number of comorbidities and the person’s risk of experiencing
hypoglycaemia.(7) The health interventions conducted by healthcare professionals
and consequent improved clinical outcomes may lead to enhanced quality of life
(QOL).
3
The World Health Organization (WHO) defines QOL as a person’s perception of their
life in the culture and system where they live associated with their life’s goals ,
expectations and concerns.(11) QOL scores reflect a person’s self management of
their disease.(16) A higher QOL score is associated with better clinical outcomes and
less anxiety about the disease.(11) A lower score of diabetes QOL is presented among
patients with multiple comorbidities.(18, 19) One determinant of increased QOL
scores is patient education on diabetes self management.(16) The QOL questionnaire
used in the thesis was the validated World Health Organization QOL abbreviated
questionnaire (WHOQOL-BREF) assessment, the Bahasa Malaysia version. It consists
of 26 questions which is grouped into four domains and its corresponding 24 facets.
The 24 questions were derived from each of the 24 facets. The additional two
questions asks a person’s perception on their overall general health and QOL. The
domains and their facets are as follows: (11)
1. Physical health: Activities of daily living, dependence on medication and
medical aids, energy and fatigue, mobility, pain, sleep and work ability
2. Psychological: body image, negative and postive feelings, self esteem,
religion, spirituality, personal belief, thinking, learning, memory and
concentration.
3. Social relationships: personal relationships, social support and sexual activity
4. Environment: financial resources, freedom, physical safety, accessibility to
health and social care, home environment, opportunities for acquiring new
information and skills, participation in recreational and leisure activities,
physical environment such as noise, pollution, transport.
1.1.2 Pharmacological treatment of T2DM
The different classes of medications involved in treating increased blood glucose
levels (BGL) are oral hypoglycaemic agents (OHA) such as biguanides, sulphonylureas,
4
DPPIV inhibitors, thiazolidinedione, acarbose and the SGLT 2 inhibitors while the
injectables consists of insulin and GLP1 agonists.
The standards of care, American diabetes association(16) recommends metformin as
first choice to achieve HbA1c goals if non pharmacological interventions were
ineffective. If goals are still not achieved after three months of metformin
monotherapy then dual therapy is recommended such as metformin and
sulphonylurea or other combinations with metformin. If after three months patients
still fails to achieve the glycaemic target agreed, then triple drug combination shall
be added such as metformin and sulphonlyurea and insulin or other combinations
with metformin depending on patient factors. The patient factors include, weight
issues, frequency of hypoglycaemia and CVD symptoms. Finally if three months of
triple therapy which includes OHA does not produce the targeted outcome, then
patients should be initiated on insulin specifically on basal insulin before addition of
other insulin. Diabetes guidelines from Australia, Malaysia, the UK and the USA
similarly recommend insulin initiation in patients whose HbA1c levels cannot be
achieved despite being on two or three oral hypoglycaemic agents.(6, 7, 16, 17)
1.1.3 Role of pharmacists in diabetes management
Patients with diabetes often present themselves with multiple comorbidities and
medications and therefore require complex care. Increased health burden costs due
to diabetes has prompted countries like Australia, Malaysia and the UK to utilise
pharmacists to promote medication adherence, reduce medication-related
hospitalisations and medication wastage. Consequently, pharmacists in the
community and primary health care settings provide medication management
services (MMS) that include working with patients on non-compliance issues,
managing patients with multiple chronic disease conditions and regularly educating
patients to improve quality use of medications. MMS pharmacists work in
5
collaboration with other healthcare professionals with the aim to improve patients’
clinical and QOL outcomes.
In Australia, the MMS service for patients with diabetes is known as diabetes
MedsCheck and is provided in community pharmacies. Pharmacist conduct
medication review, provide education and counselling and promote medication
adherence. In Malaysia, the diabetes MMS is known as Medication Therapy
Adherence Clinic (MTAC diabetes), but unlike Australia it is provided in primary health
care clinics and at hospital outpatient departments. Similar to Australia, MTAC
diabetes pharmacists conduct comprehensive medication review, provide education
and counselling in order to increase patients’ medication adherence and compliance
to disease management. In addition, MMS pharmacists in both countries offer
recommendations to prescribers to optimise treatments to achieve therapeutic
targets and prepare a follow up care plan for patients. Diabetes guidelines from
Australia, Malaysia, the UK and the USA outline seven diabetes factors required to
reduce the complications mentioned above.(6, 7, 16, 17) To date, there is a lack of
diabetes intervention studies evaluating a process followed by pharmacists that
addresses all seven guideline discrete factors required to be monitored. This
provided an opportunity to develop and evaluate a tool that was able to assist
pharmacists deliver targeted diabetes care of consistent quality, and in accordance
with evidence-based recommendations.
1.2 Overview of research
This research involved the development, evaluation and application of a tool that
incorporated all seven factors and was conducted in Australia and Malaysia. While
Australia’s and Malaysia’s healthcare systems differ, the diabetes practice guidelines
and existing medication management services (MMS) are similar in both countries.
6
In addition, both countries have increasing prevalence of T2DM and similar concerns
of the rising health and cost burdens.
The overall aim of this research was to:
i) develop and validate a structured pharmacist type 2 diabetes (T2DM)
intervention tool, referred to as the Simpler™ tool;
ii) explore the impact of targeted training addressing pharmacists’ knowledge
and ability to deliver evidence-based diabetes care and
iii) determine the effectiveness of a multifactorial evidence-based diabetes
intervention tool among T2DM patients.
The intention was for the tool to be incorporated into existing MMS, namely the
Australian Diabetes MedsCheck services and the Malaysian MTAC Diabetes.(4, 10)
The tool was expected to guide pharmacists with limited clinical experience to
enhance the quality of diabetes care.
This thesis is composed of six chapters and the research comprised of three phases;
Phases One, Two and Three. A mixed methods approach were selected during the
development and evaluation process. Findings from each phase were used to inform
the methodology of the next phase. Throughout this thesis, the term ‘diabetes
management’ will referred to as T2DM management. Figure 1.1 summarises the
phases of this research and the corresponding chapters.
7
Figure 1.1: Overall thesis outline
Chapter 2 provides a comprehensive review of current literature on T2DM and the
role of pharmacists in management of diabetes until August 2017. The chapter
begins with the prevalence and complications of diabetes in Australia and Malaysia.
This is followed by evidence-based management approach and the effectiveness of
multifactorial interventions in the provision of diabetes care. The significance of
patient centred care provided by pharmacists in diabetes management
internationally is discussed. This is then followed by its relevance in the primary
healthcare settings in Australia and in Malaysia. Finally, possible intervention
strategies are reviewed. The chapter ends with the overall thesis research area.
Thesis outline
Chapter 1
Introduction
Chapter 2
Literature review
Chapter 3
Phase One research
Chapter 4
Phase Two research
Chapter 5
Phase Three research
Chapter 6
General discussion and conclusion
8
The following chapter, Chapter 3 reports the findings of Phase One of the research.
Phase One developed and validated a diabetes intervention tool. The development
of the tool involved identifying and listing the seven factors of T2DM and the
corresponding therapeutic recommendations. The validation of the contents and
design input were obtained through the Delphi process. Chapter 3 begins with a brief
introduction of the Delphi process and justification for use in this research. The
methods and results sections follows, presenting findings from the Delphi
questionnaire.
Chapter 4 presents Phase Two research. Phase Two research which pilots the tool,
the Simpler™ tool, among community pharmacists in their practice settings in
Australia and Malaysia and explores their views and perceptions of the tool. Prior to
pharmacists using this tool in practice, a training package was developed to train
pharmacists to make evidence-based recommendations incorporating the tool.
Subsequently the tool and the training package were refined based on their
recommendations. The chapter begins with an introduction followed by an
explanation of Phase Two and the study design, participant recruitment from both
Malaysia and Australia, development of the Simpler™ training modules and format
of the training sessions. It then describes the interview guide, data collection process
and analysis followed by a discussion.
Chapter 5 reports the methodology and findings of Phase Three research which
comprised of a randomised controlled trial (RCT). The RCT was a parallel, six months
study conducted at seven primary health clinics located as six districts in the state of
Johor, Malaysia. Fourteen pharmacists without any formal diabetes training were
trained to provide targeted diabetes interventions using the Simpler™ tool to T2DM
patients. Patients were randomised to receiving care from pharmacists using the
Simpler™ tool and to receiving the usual customary care. Chapter 5 begins with an
introduction to the Phase Three research, followed by the research objectives and
9
method. The Simpler™ format is used to present results and discussion whereby each
letter of the word represents one of the seven aforementioned diabetes factors.
The thesis ends with Chapter 6 which provides the overall discussion and conclusion.
In addition, it outlines the overall significance of the research particularly the benefits
of utilising the tool in practice settings.
1.3 Research questions
The framework of this thesis was guided by the research questions below:
1. Can an intervention tool that comprises all the seven required diabetes factors
reduce glycated haemoglobin (HbA1c) by 1 or more%?
2. Can pharmacists without extensive formal diabetes management training using
the tool improve clinical and quality of life (QOL) outcomes among T2DM
patients?
3. Is the tool relevant and feasible for application in the community or primary
care practice settings?
11
2.1 Introduction
Sections of this chapter were published in:Ayadurai, S., Hattingh HL, Tee LBG, Md Said
SN (2016). "A Narrative Review of Diabetes Intervention Studies to Explore Diabetes
Care Opportunities for Pharmacists." Journal of Diabetes Research 2016: 11. A link to
the paper is at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4877480/.
Chapter 2 provides a comprehensive review of current literature on type 2 diabetes
mellitus (T2DM) until September 2017. The chapter begins with the prevalence and
complications of diabetes in Australia and Malaysia. This is followed by evidence-
based management and the effectiveness of multifactorial interventions in the
provision of diabetes care. The significance of patient centred care provided by
pharmacists in diabetes management internationally is then discussed. This is then
followed by its relevance in the primary healthcare setting in Australia and in
Malaysia. The chapter then moves on to review possible intervention strategies.
Finally, the chapter ends with the overall aims of the thesis.
2.1.1 Prevalence of diabetes and its complications
Globally 422 million people in 2014 had diabetes which is 8.5% of the adult
population.(15) The reported prevalence of diabetes among Malaysian adults (> 18
years) was 14.9% in 2006 and increased to 15.2% in 2011, according to a National
Health and Morbidity Survey.(20) A more recent 2015 of the same survey found that
the prevalence has further increased to 17.5%.(21) Although Australian diabetes
prevalence statistics are lower, there has been an increase from 4.1% in 2008 to 5.1%
reported in 2014-2015 among adults (>18 years).(22)
12
With the increasing prevalence of diabetes, health professionals are required to be
knowledgeable about the need for appropriate glycaemic control and measures to
prevent long-term diabetes complications. At an international level, 2012 data
showed that non-communicable diseases (NCD), comprising cardiovascular diseases
(CVD), diabetes, obesity, cancer and respiratory diseases, caused an estimated 38
million deaths per year. Diabetes alone caused 1.5 million deaths worldwide which
was an increase from 1 million in 2000. It is the eighth leading cause of death with
the number one being ischaemic heart disease.(23)
Australia seems to have a higher percentage of patients with macrovascular
complications such as cardiovascular disease (CVD) compared to Malaysia. In the
2014-15 Australian Health Report, 63% of patients with diabetes reported having
CVD(22) compared to the 2013 Malaysia Diabcare study, which showed that, of the
1688 patients studied, 15.7% had angina and 18.4% had suffered from a myocardial
infarction. Malaysia had a higher percentage of patients suffering from microvascular
complications. According to the Malaysia Diabcare study,(41%) had neuropathy and
(31.5%) had cataracts.(24) In comparison, 37% of new cases of chronic kidney disease
in Australia were caused by diabetes nephropathy while 5.9% of patients with
diabetes hospitalised were owing to diseases of the eye.(22, 25)
2.1.2 Evidence-based diabetes care
There are several key landmark trials that have provided evidence to improve the
outcome of T2DM management. These trials are as follows:
1. United Kingdom Prospective Diabetes Study (UKPDS)(26),
2. Action in Diabetes and Vascular Disease: Preterax and Diamicron MR
Controlled Evaluation(ADVANCE)(27),
13
3. Veterans Affairs Diabetes Trial (VADT)(28),
4. Diabetes Control and Complications Trial (DCCT)(29), and
5. Action to Control Cardiovascular Risk in Diabetes (ACCORD)(30)
Table 2.1 provides a brief summary of these trials. The findings from these studies
propose three main factors that need to be addressed in order to achieve treatment
goals and prevent diabetes complications in clinical practice. These factors are
glycemic control, blood pressure (BP), and cholesterol control. These factors are
incorporated into diabetes practice guidelines in Australia, Malaysia, the UK and the
USA.(6, 7, 16, 17) A 2011 concensus report by the American Diabetes Association
indicated that diabetes management that follows these practice guidelines results in
better disease control. The report noted a reduction in several diabetes
complications, such as kidney failure and amputation, as more patients receive
guideline-adherent therapy.(31)
14
Table 2.1: Landmark diabetes trials
Trial n Country
Measure Outcome Conclusion
UKPDS (26)
5102 UK-(White Caucasion, Afro-Caribbean, Asian-Indian)
Patients with T2DM. Intensive blood glucose control using metformin [to achieve HbA1c 7% (53mmol/mol] vs conventional treatment. Patient followed up for median of 10.7 years. Intensive BP control (less than 150/85 mm Hg). Efficacy of captopril or atenolol as antihypertensive and in controlling microvascular & macrovascular complications.
The trial managed to reduce mean difference of HbA1c to -1%. Therefore it produced significant risk reduction [12% (107.7mmol/mol)] for any diabetes related end point, 25% risk reduction for microvascular end points, 21% risk reduction for retinopathy and 33% risk reduction for albuminuria at 12 years, 16% risk reduction for myocardial infarction. Significant effect on microvascular and macrovascular complications. Captopril and atenolol were equally effective antihypertensive in preventing microvascular & macrovascular complications
• Intensive glycaemic control reduced microvascular complications, not mortality
• Insulin and sulphonlyureas were effective.
• Metformin was effective in obese patients
• Intensive BP control reduced micro and macrovascular complications and mortality
• Optimum targets: HbA1c<7% (53mmol/mol), BP< 140/80 mm Hg
15
Trial n Country
Measure Outcome Conclusion
ADVANCE (27)
10000 20 countries from Asia, Australia, Europe and North America
Patients with T2DM. Intensive lowering of blood glucose to HbA1c of 6.5% (47.5mmol/mol) (gliclazide MR in addition to other therapy) and BP (perindopril/indapamide combination) than UKPDS trial. Median follow up of 5 years
Trial stopped early at 4.3 years. Indapamide and perindopril combination reduced mortality, reduced weight gain, CVD events and nephropathy irrespective of baseline BP. Severe hypoglycaemia more frequent in intensive arm (2.7%) vs 1.7% in control group but this difference was not significant.
• Demonstrated that mean HbA1c=6.5% (47.5mmol/mol) can be achieved and remain at same level for 4.3 years using gliclazide MR, metformin and insulin.
• No significant difference between European and Asian patients for glycaemic control. Severe hypoglycaemia and hospitalization
• Current guidelines recommends HbA1c 6.5-7% (47.5-53mmol/mol) based on results from ADVANCE trial.
DCCT (32)
1441 29 medical centres in USA and Canada
Using three or more daily injections compared to conventional treatment (one or two insulin injections daily) among patients with Type 1 diabetes. Mean follow up of 6.5 years.
Intensive therapy reduced microalbuminuria by 39%, albuminuria by 54%, neuropathy by 60%, progression of retinopathy reduced by 54%, risk of retinopathy reduced by 76%. Significant weight gain and diabetes ketoacidosis were reported more on intensive arm
• Findings recommend intensive therapy for Type 1 DM but did not generalise to T2DM.
• Risk of hypoglycaemia in elderly likely with intensive control with insulin.
• Recommendations to intensify treatment for younger patients and
16
Trial n Country
Measure Outcome Conclusion
individualise goals for older patients.
ACCORD (33-35)
1.10251 2. 4733 3. 5518
USA and Canada
1. Patients with T2DM. Intensive intervention to control hyperglycaemia to less than HbA1c of 6.0% (42.1mmol/mol). 2. Two targets for systolic levels in BP control (<120 vs <140) 3. Two regimens for plasma lipid levels. fenofibrate and simvastatin vs simvastatin alone Mean follow up of 3.4 years.
All-cause mortality was significantly greater in the intensive arm. No reduction in macrovascular, mortality or myocardial infarctions. No significant difference between the two arms
• Lowering BP and lipid levels to below recommended levels did not reduce CVD events significantly compared to the control group.
VADT (36)
1791 USA Patients with T2DM, mean age 60.4 years followed up for 5.6 years. Comparison between intensive (metformin & rosiglitazone, glimepiride & rosiglitazone) and standard glucose control.
No significant difference in the rates of CVD events, death or microvascular complications between two groups. More hypoglycaemia (24.1%) in intensive group and 17.6% in standard therapy group.
• Intensive glucose control did not decrease the rate of CVD events.
• Minimum effect on reduction of microvascular complications
ACCORD= Action to control cardiovascular risk in diabetes; ADVANCE: Action in diabetes and vascular disease: Preterax and diamicron MR controlled evaluation trial; BP=blood pressure; CVD=cardiovascular disease; DCT=Diabetes Control and Complications trial; HbA1c= glycated haemoglobin; n=sample size; UKPDS=The United Kingdom prospective diabetes study; VADT=Veteran affairs diabetes trial
17
However, there is evidence that guidelines are not always being followed in clinical
practice. In a recent cross-sectional study, it was found that among 650 Malaysian
outpatients, 32.1% of patients with T2DM and hypertension were not on
antihypertensive such as an angiotensin converting enzyme inhibitors (ACEI) or
angiotensin receptor blockers (ARB) as per guideline recommendation. Even though
the patients had no contraindications to these antihypertensives.(37) A similar study
conducted among 430 Australian patients with diabetes found evidence-based
practice gaps especially in the prescribing of antihypertensive and lipid lowering
medications.(38) Findings from another study in Sydney, Australia, indicated that
among 118 patients with chronic disease including diabetes in eight general practices,
less than 30% of patients received intervention relating to diet and exercise.(39)
2.1.3 Pathophysiology of T2DM
T2DM is typified by hyperglycaemia and is associated with resistance to insulin,
insufficient insulin secretion and excessive glucagon secretion. An increase of blood
glucose is caused by increased carbohydrate intake, increased synthesis of hepatic
glucose, decreased insulin secretion and consequently decreased peripheral glucose
uptake. In addition it is also characterized by declining β-cell function and ultimately
to β-cell failure. Literature postulates the cause of declining β-cell function to be due
to intraislet accumulation of glucose metabolites.(40)
Current studies have suggested insulin resistance to be the main factor in the
pathogenesis of diabetes.(41) However, studies have found obesity can increase the
intraabdominal adipose tissue associated with insulin resistance even though patient
does not suffer from diabetes.(42) Furthermore, insulin resistance is found in
18
hypertension, hyperlipidemia, and heart disease.(43) These conditions are the main
comorbidities of person with T2DM. In the case of hepatic insulin resistance, a
decrease in glucokinase action increases the conversion of substrates to glucose even
though insulin is present.(44) Additionally, free fatty acid levels identified in T2DM
may lead to increased glucose production in the liver.(45) Recent studies have
suggested increased action of gluconeogenesis in the kidney as the cause of further
glucose production in the kidney.(46)
The symptoms of T2DM include polyuria, polydipsia, polyphagia and weight loss,
blurred vision and lower-extremity numbness. Diet and exercise have been shown to
improve weight especially in obese patients. Current diabetes guidelines from
Australia, Malaysia, the UK and the USA recommend diet and exercise as treatment
and suggests pharmacological intervention if goals of therapy are not achieved within
three months.(6, 7, 16, 17)
2.1.4 Pharmacological treatment of T2DM
The different classes of medications involved in treating increased BGL are oral
hypoglycaemic agents (OHA) such as biguanides, sulphonylureas, DPPIV inhibitors,
thiazolidinedione, acarbose and the SGLT 2 inhibitors while the injectables consists of
insulin and GLP1 agonists.
The standards of care, American diabetes association(16) recommends metformin as
first choice to achieve HbA1c goals if non pharmacological interventions were
ineffective. If goals are still not achieved after three months of metformin
19
monotherapy then dual therapy is recommended such as metformin and
sulphonylurea or other combinations with metformin. If after three months patients
still fails to achieve the glycaemic target agreed, then triple drug combination shall be
added such as metformin and sulphonlyurea and insulin or other combinations with
metformin depending on patient factors. The patient factors include, weight issues,
frequency of hypoglycaemia and CVD symptoms. Finally if three months of triple
therapy which include OHA does not produce the targeted outcome, then patient
should be initiated on insulin specifically on basal insulin before addition of other
insulin. The pharmacotherapy of each class of drug is summarised in Table 2.2.
Diabetes guidelines from Australia, Malaysia, the UK and the USA similarly
recommends insulin initiation in patients whose HbA1c levels cannot be achieved
despite being on two or three oral hypoglycaemic agents.(6, 7, 16, 17)
20
Table 2.2: Pharmacotherapy of diabetes medications and its related trials on CVD risk reduction outcome
Diabetes medications
Class (example)
(2) Mode of action
(6) HbA1c (1%)
reduction
(6) Hypoglycaemia
(6) Weight change
(6) CVD risk
reduction
(2) Side effects
(47) CVD outcome trials
Biguanides (Metformin)
Increase insulin sensitivity and glucose uptake into cells, inhibition of hepatic gluconeogenesis, delay in glucose absorption
1.0-1.5 Neutral Possible benefit
Possible benefit
GI symptoms, absorption of vitamin B12 may be impaired.
UKPDS(26), ACCORD(30), VADT(28)
Sulphonylurea (Gliclazide)
Inhibition of hepatic glucose production and increased sensitivity to insulin
0.4-1.6 Increased risk Increased risk
Neutral GI disturbances and increased appetitie. Rashes may occur
ADVANCE(27), ACCORD(30), VADT(28)
Glinides/ Meglitinides (Repaglinide)
Increase insulin sensitivity
1.0-1.2 Minimal risk Minimal risk
Neutral GI symptoms, back and joint pain.
ACCORD(30)
Alfa glucosidase inhibitor (Acarbose)
Slows digestion and absorption of carbohydrates in the small intestine.
0.5-0.8 Neutral Neutral Neutral GI symptoms, reversible increase in liver enzyme can occur
ACCORD(30)
Thiazolidinediones/TZD (Rosiglitazone)
Improves insulin sensitivity in adipose tissue, skeletal muscel and the liver
0.5-1.4 Neutral Increased risk
Neutral Increased apetitie, GI symptoms, headache,
ACCORD(30), VADT(28), PROactive(47), RECORD(47)
21
Diabetes medications
Class (example)
(2) Mode of action
(6) HbA1c (1%)
reduction
(6) Hypoglycaemia
(6) Weight change
(6) CVD risk
reduction
(2) Side effects
(47) CVD outcome trials
reductions in haemoglobin and haematocrit can occur.Increase bone fracture in women.
Dipeptidyl peptidase-4 inhibitors/DPP4-I (Sitagliptin)
Inhibits DPP4, an enzyme involved in degradation of incretin homornes, GLP-1 and glucose-dependent insulinotropic polypeptide (GIP).
0.5-0.8 Neutral Neutral Neutral Headache, dizziness and GI symptoms
SAVOR-TIMI53(47), EXAMINE(47), TECOS(47)
Sodium-Glucose co-transporter 2 inhibitors /SGLT2-I (Empagliflozin)
Enhances urinary excretion of glucose by suppressing renal glucose reabsorption.
0.2-0.8 Neutral Beneficial Posible benefit
Dysuria, polyuria, and genital and urinary-tract infections, dyslipidaemia and increased haematocrit. Fall in blood pressure.
EMPA-REG OUTCOME(47)
22
Diabetes medications
Class (example)
(2) Mode of action
(6) HbA1c (1%)
reduction
(6) Hypoglycaemia
(6) Weight change
(6) CVD risk
reduction
(2) Side effects
(47) CVD outcome trials
Glucagon-like peptide-1 receptor agonists/GLP-1 RA (Liraglutide)
Stimulate insulin secretion, suppress glucagon secretion and slows gastric emptying, promote beta cell proliferation
0.5-1.4 Neutral Beneficial Neutral GI symptoms, nausea but decrease with continued therapy. Rashes and hypersensitivity, acute pancreatitis.
ELIXA(47), SUSTAIN-6, LEADER(47), ACCORD(30)
Insulin (Glargine) Inhibits hepatic glucose production and enhances peripheral glucose conversion. Inhibits lipolysis therefore prevents formation of ketone bodies. Consists of short acting, intermediate, basal and premix.
>1.5 Increased risk Increased risk
Neutral Excessive dose can cause hypokalaemia. Lipoatrophy. Blurred vision and oedema may occur in the first few weeks.
DCCT(29), ACCORD(30)
ACCORD= action to control cardiovascular risk in diabetes; ADVANCE: Action in diabetes and vascular disease: preterax and diamicron MR controlled evaluation trial; CVD=cardiovascular disease; DCCT=diabetes control and complications trial; ELIXA=evaluation of lixisenatide in acute coronary syndrome trial; EXAMINE=cardiovascular outcomes study of alogliptin in patients with type 2 diabetes and acute coronary syndrome; EMPA-REG outcome=empagliflozin, cardiovascular outcomes and mortality in type 2 diabetes trial GI=gastrointestinal symptoms; HbA1c=glycated haemoglobin A1c; PROactive= prospective pioglitazone clinical trial in macrovascular events; LEADER=liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results trial; RECORD=rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2
23
Diabetes medications
Class (example)
(2) Mode of action
(6) HbA1c (1%)
reduction
(6) Hypoglycaemia
(6) Weight change
(6) CVD risk
reduction
(2) Side effects
(47) CVD outcome trials
diabetes; SAVOR-TIMI53= saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-Thrombolysis in myocardial infarction53; SUSTAIN-6=trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes; TECOS=trial to evaluate cardiovascular outcomes after treatment with sitagliptin; UKPDS=The United Kingdom prospective diabetes study; VADT=veteran affairs diabetes trial
24
2.2 Multifactorial intervention
Diabetes management aims to achieve a range of outcomes such as the reduction of
microvascular and macrovascular complications, improvement in QOL and prevention
of premature mortality.(6, 7, 16, 17) The main aim of treatment in diabetes
management is to prevent short term and long term diabetes related complications
which consists of macrovascular and microvascular diseases. The example of
macrovascular complications are cardiovascular disease such as coronary artery
disease which may cause heart attacks; peripheral artery disease leading to gangrene;
carotid artery disease leading to strokes or dementia. The examples of microvascular
complications are kidney, eye and nerve damage, which may result in erectile
dysfunction.(48)
In order to achieve these outcomes, there is a need to address multiple factors in
diabetes management, also known as multifactorial intervention. Guidelines from
Malaysia, Australia, the UK and the USA outline seven important issues that need to
be addressed inpatients with diabetes in order to achieve therapeutic goals.(6, 7, 16,
17) These are glycaemic, cholesterol, and blood pressure (BP) control, in conjunction
with management of education, medication, lifestyle and CVD risk. These factors are
summarised in Figure 2.1.
25
Figure 2.1: The multiple factors involved in providing diabetes care management
2.2.1 Cholesterol control
Patients with diabetes are at risk of developing CVD due to the macrovascular
complications of the disease. Guidelines from Malaysia, the UK and the USA stress the
importance for patients to be on a lipid-lowering medicine, namely a statin, unless
contraindicated.(6, 7, 16, 17, 49-51)
In contrast, the Australian RACGP guidelines for T2DM updated their recommendation
to use statins only in patients with known CVD regardless of their lipid levels based on
evidence from two trials which reported increased fasting serum glucose and HbA1c
with statin use.(52, 53) However a recent review in 2016 proposes a strong need to
start or continue statin treatment as the benefits of statin in terms of cardiovascular
risk reduction among patients with diabetes outweighs the rare risks of myopathy and
muscle related symptoms.(54)
Diabetes Management
SStatin/
cholesterol IInsulin/
Glycaemic
MMedication
PBlood
Pressure
LLifestyle
EEducation
RCVD Risk
26
2.2.2 Glycaemic control
While patients on insulin and oral hypoglycemic agents may suffer from
hypoglycaemia, it has been observed that reducing hypoglycaemia episodes is
associated with increased patient adherence and satisfaction with medication.(55)
The results from the landmark trials mentioned in section 2.1.2, highlight several
factors that need to be addressed to prevent hypoglycaemia such as individualised
glycemic targets, education of patients on hypoglycaemia awareness, self monitoring
of blood glucose (SMBG), adjusting therapy and changing to treatment that causes low
risk of hypoglycaemia.(56-59) WHO recommends glycated haemoglobin (HbA1c) to
be measured twice a year in T2DM.(15) HbA1c is the chosen method to measure
blood glucose level (BGL) as it gives an average value based on the past three months.
However, due to its high cost, fasting or post prandial glucose levels are equally
accepted methods to measure BGL.(15)
Previous studies have documented twice the risk of acquiring CVD complications
among patients with diabetes compared to patients without the disease.(60)
Glycemic control measures should aim to reduce glycated haemoglobin (HbA1c)by 1%
or more for patients whose HbA1c is more than 7% (53mmol/mol) as this can produce
significant reduction in macrovascular and microvascular complications, as shown in
the UKPDS trial.(26) The UKPDS trial consisting of 4585 white, Asian Indian and Afro-
Caribbean T2DM patients found that 1% reduction in HbA1c (glycated haemoglobin)
was associated with reductions of:
1) 21% risk for a diabetes related death,
2) 14% risk of myocardial infarction
3) 37% risk for microvascular complications
27
The researchers in the same study found the lowest risk of complications were those
with HbA1c less than 6% (42.1mmol/mol). However, results from the ADVANCE and
ACCORD trial found that lowering HbA1c to less than 6% (42.1mmol/mol) and systolic
blood pressure to less than 120 mmHg resulted in increased hospitalisations,
hypoglycaemia and mortality in the intervention group.(27, 30) The results from these
studies strongly suggest that blood glucose and BP targets should be individualised for
each patient. The findings were incorporated into diabetes practice guidelines in
Australia, Malaysia, the UK and the USA.(6, 7, 16, 17)
2.2.3 Medication management
Medication management requires that each patient’s drug (medicine) related needs
be addressed to achieve optimal therapeutic outcomes. The role of pharmacists has
developed over the last few decades into the provision of medication management
services, with pharmacists providing pharmaceutical care in addition to the
management and dispensing of medications. Pharmaceutical care was originally
defined by Hepler and Strand in 1990 as identifying, resolving and preventing
MRPs.(61) Pharmaceutical care is also used interchangeably with patient centred
care.(62) Patients taking medications often have MRPs, especially patients who are
on multiple medicines. The types of MRPs are defined as below.(63):
1) Wrong medicine-contraindicated
2) Underdose/overdose
3) Medications not adjusted for renal failure
4) Non-adherence to medications
5) Adverse drug reaction
6) Drug-drug,food-drug, drug-herbal interaction
7) Unnecessary medicine use
28
Pharmacists ability to detect these MRPs mentioned above were documented in a
2012 study conducted in Malaysia. Of the 477 patients included in the study, 157
(33.3%) had MRPs, 74(15.6%) had developed adverse drug reactions, 45(9.5%) were
not prescribed the most effective medicine and 16 (3.4%) had dosing problems.(64)
Several studies have suggested that patients with diabetes who are adherent with
taking their medication can reduce the overall health care burden even though this
could mean an increase in medication costs.(65-69) A randomised, prospective study
of 107 patients with diabetes who were followed up for two years found adherence
to medication was the strongest predictor of reaching the target HbA1c.(70) However,
patient’s reluctance to start or administer prescribed insulin remains a biggest
hindrance to achieve glycaemic goals.
2.2.3.1 Psychological barriers to insulin adherence
In two recent studies conducted in Malaysia, patients perceived barriers were found
to be religious purity of insulin, negative effects of insulin therapy such as fear, lifestyle
restriction, hypoglycaemia and negative social stigma while healthcare professionals
(HCP) barriers were lack of resources, language and communication skills.(71, 72)
These perceived patients’ barriers were similar to patients in other parts of the world
as reported in a 2008 systematic review (73) and in a 2012 large scale survey
conducted in China, France, Japan, Germany, Spain, Turkey, The UK and the USA.(74)
The results from the 2012 Diabetes, Attitudes, Wishes and Needs (DAWN) Japanese
study on GP’s barriers towards insulin initiation were concerns of using insulin among
elderly patients and lack of support in providing insulin education to patients.(75)
29
Correspondingly, findings from a recent Australian primary care study conducted in
2016 reported only one in five patients reported ‘very willing’ to start insulin. The
authors also found that reduced negative attitude towards insulin were related to
higher socioeconomic status.(76) To overcome the perceived misconception that
insulin is the “last resort” option or “punishment” for treatment failure, both GPs and
patients should be educated about the requirement of insulin with increased disease
duration.(77) Previous studies have shown that early intensive insulin in newly
diagnosed T2DM patient can delay the need for OHA medications. Insulin initiation
within two years of diagnosis was most efficient in these studies.(78, 79) In addition,
pharmacists need to identify the risk factors associated with insulin non-adherences
such as lifestyle burden, difficulty in insulin administration and adaptation to injection
timing as shown in literature.(80)
2.2.4 Blood pressure (BP) control
BP that is less than 150/85 mmHg has been demonstrated to reduce microvascular
and macrovascular complications, as noted in the UKPDS trial.(26) The 2016-2018
Royal Australian College of General Practitioners, the American diabetes association’s
standards of medical care in diabetes and the National Institute for Health and Care
Excellence, United Kingdom guidelines recommends a target of less than 140/90
mmHg for all patients with diabetes and 130/80 mmHg for those with
microalbuminuria or proteinuria.(7, 16, 17) In contrast, the 2015 Malaysian Ministry
of Health diabetes clinical practice guideline recommends a standard target of 135/75
mmHg or less.(6) These guidelines strongly recommend prescribing, unless
contraindicated, an Angiotensin Converting Enzyme inhibitor (ACEI) or an Angiotensin
Receptor Blocker (ARB).(6, 7, 16, 17) However, there is evidence that guidelines are
not always being followed in clinical practice. A 2013 cross sectional study found that
30
among 650 Malaysian outpatients, 32.1% of patients with diabetes with hypertension
were not on any antihypertensive such as an ACEI or ARB, as per guideline
recommendation, although these patients had no contraindications to these
antihypertensives.(37) A similar study conducted among 430 Australian patients with
diabetes in 2011 found evidence-based practice gaps, especially in the prescribing of
antihypertensive and lipid lowering medications.(38)
2.2.5 Lifestyle management
In the Look AHEAD trial on obese T2DM patients, the intervention group had intensive
lifestyle intervention on behaviour, nutrition and exercise while the control group only
had education on diabetes management. The study significantly improved weight loss
and fitness in the intervention group, subsequently increasing the number of
participants achieving HbA1c<7% (53mmol/mol) from 46% at baseline to 73% at final
study. In contrast, the education only group achieved 5% increase in the number of
participants who achieved the targeted HbA1c.(81) Although evidence from
numerous studies highlight the glycaemic lowering benefits of lifestyle management
in diabetes, lifestyle intervention remains a problem. In a 2009 study conducted in
Sydney, Australia, found that among 118 patients with chronic disease, including
diabetes from eight general practices, less than 30% of patients received intervention
on diet and exercise.(39) Of interest, a 2016 study conducted in the UK found patients
with diabetes preferred demonstrating compliance to medications rather than to
make lifestyle changes.(82)
31
2.2.6 Education provision
A systematic review study on 42 RCTs concluded that diabetes education on self-
management could reduce the risk of diabetes related mortality.(83) The types of
education provided included importance of medication adherence, lifestyle
modification and monitoring of BGL. In Australia, the Diabetes Mellitus Education
Programme (DMEP) conducted in 2006 showed significant improvement in glycaemic
and blood pressure control, weight loss and understanding of diabetes
management.(84) The DMEP was part of the Third Community Pharmacy Agreement
under the Australian Government Department of Health & Ageing. In addition, the
diabetes education and self-management for ongoing and newly diagnosed
(DESMOND), is currently available for T2DM patients in Western Australia. DESMOND
aims to provide education on weight loss, smoking cessation and instils positive beliefs
about diabetes. The DESMOND education intervention for T2DM patients originally
conducted in the UK was found to be more cost effective.(85) In Malaysia, home
based diabetes education conducted by pharmacists significantly improved
medication adherence among T2DM patients.(86)
Previous diabetes intervention studies on the self-management of foot care have
shown improved foot care among patients with diabetes.(87) In 2012-13, Australia
recorded 3570 amputations among patients with diabetes.(25) While in Malaysia, a
2013 study reported peripheral neuropathy among 41% of 1668 patients with
diabetes.(24) Therefore, proper footwear, foot hygiene and regular assessment for
neuropathy remain an important component of diabetes education to prevent
complications that lead to amputation.(15) In addition, risk of lower limb amputation
is increased by canagliflozin a SGLT2 inhibitor as advised by both the European
Medicines Agency and the US Food and Drug Administration.(88) Therefore,
32
pharmacists need to be aware of this potential adverse reaction to prevent future
complications.
2.2.7 CVD risk management
CVD risk can be estimated using risk prediction formulae. Several CVD risk prediction
formulae are therefore used worldwide. The Framingham risk score (FRS) is the most
commonly used tool, and has been adapted for use in diverse populations.(89) Other
tools include the UKPDS tool for patients with diabetes.(90) In Australia, the absolute
risk calculator was developed based on the Australian National Vascular Disease
Prevention Alliance (NVDPA) guidelines.(91) Guidelines from Malaysia (for patients
aged 65 years and above) and the USA suggest aspirin therapy (75mg-162mg/day) as
primary prevention strategy for increased CVD risk (10 year risk>10%).(6, 16)
Malaysian and USA guidelines recommend using the FRS. The UK National Institute
for Health and Care Excellence (NICE) guidelines on Type 2 Diabetes Mellitus
recommends the UKPDS risk engine for educating patients on CVD complications.(17)
2.2.8 Effectiveness of multifactorial interventions
Studies on multifactorial interventions have reported improved patient outcomes. For
instance, the 2012 ADDITION-Europe study, which was a cluster-randomised study
that involved interventions on glycaemia, BP and cholesterol control as well as
lifestyle, reported reductions in cardiovascular events and death.(92) Another 2012
study conducted in China found that addressing multifactorial interventions according
33
to practice guidelines could delay diabetes related complications such as diabetes
nephropathy.(93) The 2013 Multiple Intervention in type 2 diabetes Italy (MIND.IT), a
cluster RCT study conducted in Italy, found significant improvements in patients’
glycaemic, cholesterol and BP levels after following treat-to-target approaches which
included lifestyle and pharmaceutical interventions.(94) In the Steno-2 study
conducted in Denmark in 2003, showed the effect of a multifactorial intervention
targeting hyperglycaemia, hypertension, dyslipidaemia, microalbuminuria and
secondary prevention of CVD risks. The results showed reduction of CVD risk and
microvascular events by 50%.(95)
2.2.8.1 Diabetes interventions conducted by healthcare professionals besides
pharmacists
Despite the widely-documented evidence, recently conducted RCTs by healthcare
professionals have failed to address all the seven diabetes factors in providing
evidence-based diabetes care. Thus, diabetes interventions led by multidisciplinary
teams which comprised of nurses, dieticians, psychologists and physiotherapists
indicated improvements in some of the seven factors but not others.(96-102) This
could be due to each member of the multidisciplinary team addressing the factors
pertaining to their own expertise but not the others. For instance, certain diabetes
interventions conducted by nurses emphasised self management.(96, 99, 103, 104)
While others examined motivational interviewing to promote behavioural changes
and attitudes among patients with diabetes, which consequently produced significant
improvement in glycemic control, adherence and lifestyle changes (105-107) omiting
other CVD risk factors. Interventions that focused on four factors, namely nutrition,
blood glucose monitoring, medication taking and lifestyle resulted in significant
improvement in HbA1c and health-related QOL values.(108, 109) However, there was
no mention of improvement to other factors such as BP and cholesterol control.
34
In addition, the improvements in patients’ outcomes were from studies conducted
between three to 12 months. While there seems to be a short term improvement in
clinical outcomes, long term outcomes, especially in delaying the progression of
complications, could not be established. To address the limitations in these studies, a
common, standardised multifactorial approach with common therapy goals for each
member of the multidisciplinary team maybe beneficial.
Of interest is the effectiveness of cultural interventions documented in the diabetes
intervention study conducted by HCPs besides pharmacists, which found
improvements in problem solving skills and dietary intake but not for physical activity.
These intervention comprised of self-management; acculturation from Latino to
Mediterranean diet; stress management techniques; physical activity; smoking
cessation and problem solving skills.(110) Other diabetes studies used ‘local language’
to discuss behaviour change in lifestyle issues thus utilising culturally relevant
perspective to induce change in self-care management and this indicated a significant
improvement in HbA1c compared to the usual care.(96, 98) Table 2.3 provides a
summary of the diabetes intervention conducted by HCPs besides pharmacists.
35
Table 2.3: Types of diabetes intervention studies conducted by healthcare professionals besides pharmacists
Author, Year
Study Design
Study Duration
Country Group Size Intervention Strategy Results
*C *I
Barrera 2012(110)
RCT 12 months
USA 138 142 Culturally adapted diabetes intervention
Improvement in sources for dietary practice, problem solving, physical activity
Brennan 2012(111)
RCT 6 months
USA 24124
5123 Statin, ACEI/ARB initiation, total days of medication supply per month (adherence)
Increased adherence and GP initiation of ACEI/ARB and statin
Farmer 2012(100)
RCT 20 week UK 81 114 Intervention on adherence, reinforcement of positive belief by nurse
Percentage of adherence days in intervention group was 77.4 and usual care group was 69%
Keogh 2011(107)
RCT 6 months
Ireland 61 60 Techniques from health psychology and motivational interviewing such as exchanging information, eliciting change talk, reducing resistance, building self-efficacy, problem solving, and goal setting/action planning.
Significant lower HbA1C levels (0.66%) , significant improvements in beliefs about diabetes, psychological well-being, diet, exercise, and family support
Nishita 2013(112)
RCT 7 months
Hawaii 62 128 Pharmacists and life coach counselling
Significant effect on QOL and BMI
DePue 2013(96), Sinclair 2013(103)
RCT 3-12 months
American Samoa, Native
34-134
48-134
Culturally adapted community nurse intervention on self-
Significant reduction in HbA1c (0.5%-1.1%), understanding of diabetes self-management, performing diabetes self-management
36
Author, Year
Study Design
Study Duration
Country Group Size Intervention Strategy Results
*C *I
Spencer 2011(99)
Hawaiian and Pacific People
management among patients with diabetes
Fischer 2012(97)
RCT 6 weeks USA 381 381 Nurses independently initiated and titrated lipid therapy and promoted behavioural change through motivational interviewing and self-management techniques
Percentage of patients achieving target LDL increased in intervention group
Farmer 2012(113)
RCT 5 months
UK 85 126 Nurse led intervention to improve adherence to treatment
Significant increase in medication adherence days
Williams 2012(114) Quinn 2011(108)
RCT 6-12 months
Australia, USA
60-82
60-81 Diabetes care on nutrition, blood glucose monitoring, medication taking and lifestyle through telephone
Significant improvement in HbA1c (0.8%-1.9%) and health related QOL
Liu 2012(115)
RCT 12 months
Shanghai, China
89 119 Group visit model to support self-management
Increased duration of aerobic exercise, increase in self-management efficacy, decrease in systolic BP
Wu 2011(101)
quasi experimental
6 months
Taiwan 73 72 Self-management programmes by nurses
The scores for efficacy expectations, outcome expectations, and self-care activities had significantly increased in the intervention group at the 3 and 6month follow-ups
Kang 2010(106)
RCT 6 months
USA, Taiwan
28 28 Psychologically family intervention
Statistically significant
37
Author, Year
Study Design
Study Duration
Country Group Size Intervention Strategy Results
*C *I
improvements in HbA1c (1.35%), psychological well-being, diet, exercise, and family support
Chen 2012(105)
RCT 3 months
Taiwan 111 104 Motivational interview using Miller and Rollnick’s (2002) approach. Intervention based on readiness to change
Improvement in self-management, self-efficacy, QOL, and HbA1c (0.8%)
ACEI=angiotensin converting enzyme inhibitor; ARB= angiotensin receptor blocker; BP= blood pressure; C=control patients; HbA1c=glycated haemoglobin I=intervention patients; LDL=low density lipoprotein; RCT=randomised controlled trial; UK=United Kingdom; USA=United States of America; QOL=quality of life
38
2.2.8.2 Diabetes intervention studies conducted by pharmacists
Pharmacists’ effectiveness in improving glycaemic control in RCTs have been well
documented.(116-120) The reduced cost in hospital and emergency admissions due
to pharmacist intervention has also been documented in several studies.(118, 121)
Details of pharmacists led diabetes intervention studies are summarised in Table 2.4.
Similar to diabetes intervention studies conducted by other healthcare professionals
discussed above, intervention methods in terms of addressing the multiple factors
identified varied across RCT pharmacist studies. Patient education on medication
management and lifestyle significantly improved body mass index (BMI), HbA1c,
fasting blood glucose (FBG) and self-care management.(122-125) However, there was
no evidence if BP or cholesterol control measures were addressed. RCTs which
focused on pharmaceutical care interventions reported a reduction in HbA1c,
cholesterol and blood pressure but there was no mention of CVDrisk prevention
strategies.(84, 126-129) One study examined the impact of education, medicine
management, pharmaceutical care and lifestyle counselling, HbA1c and cholesterol
control, however there was no mention of BP control. There were also no mention of
indicated medicines for reduction of CVD risks, such as aspirin or for BP such as
antihypertensives, particularly ACEI, being prescribed.(130)
39
Table 2.4: Types of pharmacist led diabetes intervention studies
Study Design Duration
(months)
Country Group Size Intervention Method
Pharmacist background
Results
C I
Adibe
2013 (131)
RCT 12 Nigeria 110 110 Patient education on diabetes, SMBG, medications, lifestyle, effective interaction with health providers, identification of MRP
Experienced hospital pharmacists
Improved QOL
Ayadurai
2013(129)
Retrospective,cohort study
6 Malaysia - - Experienced Pharmacists running intervention programme that looks at glycaemic control, BP, CVD risk factors, education, medication adherence and lifestyle factors.
Experienced pharmacists who are trained in diabetes management.
Significant reduction in HbA1c (1.33%), medication adherence and no. of hypoglycaemia events.
40
Study Design Duration
(months)
Country Group Size Intervention Method
Pharmacist background
Results
C I
Mitchell
2011(132)
Audit 2 Australia - - Evaluation of pharmacist role in supporting DMAS
Experienced pharmacist
Community pharmacist is effective in supporting DMAS
Chan
2012(130)
RCT 9 Hong Kong
54 51 Pharmacist care on drug counselling, medication adherence, drug related problems, lifestyle counselling in addition to medical care
Experienced hospital pharmacists
Significant reduction in CVD risk, HbA1c levels (1.57%), LDL, increased level of medication understanding
Farsaei
2011(124)
RCT 3 Iran 87 87 Education on diabetes management, medication, adherence, medication taking during Muslim fasting month
Clinical pharmacist-led patient education program
Improvements in FBG, HbA1c (1.7%)
Hamarneh
2013(133)
Before and after
6 Canada n=100
Independent prescribing of glargine and
Experienced Pharmacist
HbA1c reduced from 9.1% (76mmol/mol)-7.3% (56.3mmol/mol).
41
Study Design Duration
(months)
Country Group Size Intervention Method
Pharmacist background
Results
C I
oral drugs for diabetes by Pharmacists
Improvement in fasting blood glucose
Jameson
2010(125)
RCT 12 United States
51 52 Pharmaceutical care intervention and education
Pharmacist is board-certified pharmacotherapy specialist trained in Diabetes
Improvements in HbA1c (1.0% reduction)
Jarab 2012(127)
RCT 6 Jordan 79 77 Pharmaceutical care by pharmacists
Pharmacist working in diabetes clinic
Improvements in FBG, BP, total cholesterol, LDL, medication adherence
Kumar
2011(128)
RCT 9 Malaysia 42 43 Experienced pharmacists running intervention programme that looks at glycaemic control, BP, CVD risk factors, education, medication adherence and lifestyle factors.
Experienced pharmacists who are trained as diabetes Pharmacists
Significant improvement in HbA1c (1.7% reduction), medication adherence levels and cost effective.
42
Study Design Duration
(months)
Country Group Size Intervention Method
Pharmacist background
Results
C I
Maurao 2013(126)
RCT 6 Brazil 50 50 Care plan for each patient to meet therapeutic goals, patient education and pharmacotherapy change
Community pharmacists with minimum of four years of experience, trained in diabetes management
Significant reduction of HbA1c (0.6%), FBG, total cholesterol, LDL cholesterol, TG, BP and increase in HDL
Mehuys
2011(123)
RCT 6 Belgium 135 153 T2DM education and its complications, correct use of hypoglycaemic agents, adherence, lifestyle, reminders about annual eye and foot examination
Community pharmacist underwent training session on diabetes management
Significant reduction of HbA1c (1.05%), self-management and better knowledge of diabetes
Samtia
2013(122)
RCT 5 Pakistan 170 178 Education on short and long-term complications, medication adherence, timing of
Clinical pharmacist with minimum three years of experience in
Reduced BMI and waist circumference, fasting blood glucose, HbA1c (1.01%). Increase in
43
Study Design Duration
(months)
Country Group Size Intervention Method
Pharmacist background
Results
C I
medication, before/after food, dietary restrictions, foot examination, exercise, SMBG, FBG and HbA1c, smoking cessation
hospital setting
compliance, foot care and SMBG.
Taveira 2010(134)
RCT 4 USA 28 28 Pharmacist intervention in community based primary care group
Clinical Pharmacists
Significant improvement in HbA1c (0.9%)
BMI= body mass index; BP=blood pressure; C=control patients; CVD= cardiovascular disease; DMAS= diabetes medication assistant service; FBG= Fasting blood glucose; HbA1c=glycated haemoglobin; HDL= high density lipoprotein; I=intervention patients; LDL=low density lipoprotein; n=sample size; RCT=randomised controlled trial; SMBG= self-monitoring blood glucose; T2DM= type 2 diabetes mellitus; TG=triglyceride; UK=United Kingdom; USA=United States of America; QOL=quality of life
44
Although extensive literature exists on effectiveness of pharmacists interventions in
diabetes studies, the process used by pharmacists to retrieve information and make
the interventions were rarely described as observed in a systematic review on
diabetes intervention RCTs published in 2016.(13) Undoubtedly, pharmacists with
varied experience and skills may have used their discretion when making an
intervention as stipulated in a review study.(135)
The non uniformity in the number of diabetes factors addressed may have also
contributed to the varied HbA1c reduction. For instance, RCTs which focused on
education, lifestyle and medication significantly reduced HbA1c by 0.6% in the
intervention group (n=50) vs an increase of 0.7% in the control group (n=50)](136).
While another study which focused on the same three factors reduced HbA1c to a
greater extent of 0.8% in intervention group(n=77) vs 0.1% in the control
group(n=79)(127) Since most RCTs were led by hospital pharmacists with a minimum
of three years of clinical experience (122-130, 137-142), it is uncertain if community
pharmacists with limited clinical experience can provide a similar level of
pharmaceutical care and patient outcomes. Similar views were discussed in two
review studies.(13, 14)
The variation with reference to HbA1c reduction among RCTs could also be due to
pharmacist dependence on prescriber to initiate or change medications. Previous
research findings suggest not all pharmacists recommendations are accepted by GPs.
Acceptance rate ranges from 82% to 94%.(64, 143-145) Comparatively, a review
study conducted in 2016 showed more homogenity in studies where pharmacy had
autonomy to add, change or modify dose of diabetes medications as part of agreed
protocol. However, these studies were not associated with better therapeutic
outcomes.(13)
45
2.2.8.3 Quality of life (QOL) outcome
Diabetes guidelines strongly recommend using QOL to measure the effectiveness of
healthcare interventions.(16) A 2017 review study have found that diabetes affects
QOL domains such as the physical domain when patient presents with complications
and comorbidities; the psychological domain when patient has depression or
dementia and the social domain which affects family life and relationships.(18) A
Taiwan study conducted in 2012 found that lower QOL ratings were scored by
patients with dietary restriction, higher HbA1c, using insulin and with multiple
comorbidities.(19) Thus, in providing individualised care it was deemed important to
address patients’ concerns in order for them to be compliant to treatment and
continue self management for better diabetes control.(18) A recent 2016 study
conducted in Malaysia found that existing diabetes complications, longer diabetes
duration, insulin and glycaemic control were associated with patients’ QOL. The
authors further reported that patients who were prescribed insulin to achieve ideal
glycaemic targets gave lower QOL scores.(146)
Although there was a lack of QOL studies conducted by pharmacists, yet almost all of
the studies have reported that pharmacist interventions improved QOL scores.(147)
Undoubtedly the education and counselling provided might have reduced patient
concerns and worry about the disease as found in a 2013 study conducted in
Nigeria.(137) Currently there are several health related QOL questionnaires utilised
in diabetes intervention studies. Among them are WHOQOL-BREF, EuroQOL, SF36
and the recent ADDQOL 18 and DQOL.(18) The WHOQOL-BREF will be used in this
research as it is a valid and reliable instrument which covers all health domains not
covered in other established questionnaires such as European QOL measure
(EuroQOL) and the 36-item short form health survey (SF36).(11) Furthermore, the
WHOQOL-BREF (Bahasa Malaysia language version) has also been validated among
the Malaysian population.(148)
46
2.3 Patient centred care (PCC)
Although disease guidelines stress the need to address specific issues in a particular
disease, they rarely address all of the comorbidities that a patient may suffer from.
For example, diabetes guidelines rarely mention treatment recommendations for
dementia or rheumatoid arthritis. However, patients increasingly have multiple
comorbidities and multiple medications(149) and therefore an individualised
approach is required to prevent disease burden and associated complications.
The key attributes that defines PCC is holistic, individualised, respectful and
empowering care.(150) In diabetes care, PCC is translated as having individualised
therapeutic goals in terms of glycaemic, cholesterol and BP control based on a
patient’s comorbidities, hypoglycaemia episodes and age. In addition, patients’
education on self care practice is vital to achieve therapeutic goals and consequently
increase medication adherence.(6, 7) A recent review outlined seven step guideline
when providing PCC to patients with multiple medications.(149) The steps are as
follows:
1) Conduct patient assessment
2) Determine therapeutic goals
3) Identify medication that may cause potential harm
4) Risks and benefit assessment
5) Conduct intervention
6) Communicate to other healthcare providers
7) Provide patient monitoring
2.3.1 Role of pharmacists in diabetes management
As patients with multiple comorbidites continue to rise, the increasing pressure and
workload on general practitioners (GPs) in Europe, the UK and the USA necessitate
47
collaboration with other HCPs in caring for patients with multiple comorbidites to
reduce country’s health and cost burdens.(151) For this reason, other healthcare
professionals, specifically pharmacists, are in an ideal position to provide continuity
of care, increase compliance to prevent emergency doctors’ visits and
hospitalisations, and thus reduce medical expenditure. Increased health burden
costs due to chronic disease management has prompted countries like Australia,
Malaysia and the UK to utilise primary care pharmacists to promote medication
adherence, reduce medication-related hospitalisations and medication
wastage.(152)
In Australia, between 2013 and 2014, GP services contributed to the majority(19.3%)
of the primary healthcare expenditure.(22) To improve the management of patients
with chronic disease, the Australian primary healthcare advisory group recommends
to reform primary healthcare included enhanced role for pharmacists. This involves
pharmacists and other HCP providing coordinated care in the primary healthcare
system.(153) In Malaysia, public institutions mobilised pharmacist to provide
diabetes medication management service (MMS) implemented in 2004. This was an
iniatiative of the Pharmaceutical Services Division under the Ministry of Health.(10)
Although hospital pharmacists in the UK have been conducting patient medication
reviews since the 1980’s, the medication use review (MUR) service provided in the
community sector was only implemented as part of community pharmacy contracts
in 2005.(154) The reformation on the remuneration structure in healthcare in 2016
meant better payment for community pharmacists if they provided advanced
specified services. The specified services included MUR for patients with long term
illness and on multiple medications such as diabetes.(155)
48
2.3.2 Pharmacist-provided medication management service (MMS)
MMS is an intensive care that places emphasis on PCC provided by pharmacists in
collaboration with other HCPs. It comprises of medication review, identification of
MRPs, patient education and monitoring. In addition, pharmacists are able to
address lifestyle issues such as diet and exercise which are pertinent to achieving
appropriate therapeutic outcomes, particularly in diabetes management.
Pharmacists provided MMS services in diabetes management have contributed
significantly to the improvement to patients’ clinical and humanistic QOL
outcomes.(14, 147) Randomised controlled trials in diabetes management carried
out in different parts of the world suggest that MMS pharmacists can make significant
improvements in therapeutic outcomes.(125-127, 130, 137, 138) The diabetes MMS
commonly provided by community pharmacists in Australia is known as Diabetes
MedsCheck and the Malaysian one is known as MTAC Diabetes.
2.3.3 Australian provided diabetes MMS: Diabetes MedsCheck
In Australia, the Diabetes MedsCheck program was implemented in community
pharmacies as part of the 5th and 6th Community Pharmacy Agreement (July 2010-
June 2020).(156) The Diabetes MedsCheck program is a PCC service delivered by
privately owned community pharmacists funded by the Department of Health and
Ageing. It followed an initial trial study, DMAS that demonstrated effectiveness of
trained community pharmacists in delivering self-management support to patients
with diabetes that showed improvement in clinical and health outcomes.(132)
Pharmacists providing Diabetes MedsCheck service conduct a MUR, educate patients
on the quality use of medicines, develop a plan of action, follow up patients and
document their interventions. The Diabetes MedsCheck guidelines require
pharmacists to designate an appropriate private area in their pharmacy to faciliate
49
patient consultation. The process takes about 20 minutes to complete. Based on the
number of patients with diabetes seen, pharmacists are reimbursed for their
services.(157)
2.3.4 Malaysian provided diabetes MMS: MTAC diabetes
In Malaysia, the diabetes MMS provided by pharmacists is known as MTAC Diabetes.
In comparison to Australia the Malaysian MTAC Diabetes services are provided as
part of a comprehensive service in most government hospitals which act as tertiary
referral centres and are catered to outpatients.(10) They are also provided at
government-funded primary healthcare clinics at the community level. MTAC
Diabetes involves pharmacists reviewing patients’ medication (MUR), making
recommendations to prescribers, developing a medication plan, educating patients
and counselling them on lifestyle, documenting interventions and subsequent
patient follow up for a minimum of eight visits.(10) Like Diabetes MedsCheck, MTAC
Diabetes guidelines also stipulate the requirement for a private consultation area in
close proximity with GPs when reviewing patients. Similarly, the consultation process
takes about 20-30 minutes. Cross-sectional and RCTs in Malaysia suggest that MTAC
Diabetes may improve clinical, humanistic and economic outcomes of patients with
diabetes.(86, 128, 129, 158-161)
2.4 Diabetes intervention strategy for pharmacists
There is a growing body of literature that recognises the contribution of medication-
related interventions made by pharmacist as mentioned in section 2.3.2. In addition,
pharmacist ability to optimise medication therapy, refer patients for eye examination
50
and provide yearly immunisations and other screening tests according to diabetes
practice guidelines are well recognised.(118) Yet pharmacists also express the need
for further training to upskill their competency in providing advanced services such
as medication management services.(162) The key elements identified in providing
quality intervention include having access to patient medical information, good
rapport between the general practitioners and pharmacist, written information as
the form of communicating interventions conducted and medication review.(154)
2.4.1 Requirement for targeted training program
Despite the documented patient improvements made by pharmacist providing
medication management services such as Diabetes MedsCheck and MTAC Diabetes,
the number of diabetes related complications are still trending to increase.(22, 163)
For instance, in the USA, these services were offered by 60% of community
pharmacies from 2009 to 2014 (164) yet the number of patients with diabetes visiting
doctor’s clinic increased by 20% from 2005 to 2010.(165) Although the reasons for
this increase have not been stipulated, several likely causes could be increased
dispensing workloads, lack of staff and time for pharmacists to conduct medication
reviews, as previously reported.(166, 167)
A recent study published in 2017 reviewed seven systematic review papers on
pharmacist diabetes interventions. The authors recommended further training to
address pharmacists’ competency in managing patients with diabetes.(147) Diabetes
credentialing programs offered in Australia, whilst addressing the competency issues
required by other healthcare providers in diabetes management, are not specifically
targeted to pharmacist.(168) Short term continuous professional education on the
one hand while beneficial does not address experiential training through mentoring
and supervision. A training program specifically targeted to diabetes intervention
51
competencies required by pharmacist in diabetes management would be
advantageous. Unfortunately, such training programs are scarce.
2.4.2 Pharmacist access to patient medical records (PMR)
The benefits of pharmacist access to medical records are documented in several
studies.(169-172) Pharmacist ability to conduct complete, efficient medication
reviews has been shown in an exploratory study conducted in 2017.(173) In MMS
provision, access to medical records enabled pharmacists to monitor patient
adherence, identify MRPs and coordinate care given by other health care
providers.(170) This is required to make evidence-based quality interventions in
diabetes.(154)
Although hospital pharmacists may have greater access to medical records, most
community pharmacists still face challenges in obtaining results of blood tests or
current medical interventions. In a recent 2017 review on patient’s perceptions on
pharmacist prescribing, lack of pharmacists’ access to medical records were a major
concern, particularly in terms of safe prescribing.(174)
To address this issue, several countries such as the UK, USA and Australia have
implemented electronic patient health records. In Australia, the My Health Record
was introduced in 2012, but is still in the development phase, contains medical
information such as allergies, medicine details, pathology details and current
conditions.(175) Patients have control over which persons access their records. In
the UK, the summary care record was implemented in 2015. Similar to Australia’s My
Health, the summary care records enables patients to have control over which
52
member of the healthcare providers are accessing their record.(176) Similar to
Australia and the UK, the electronic personal health record is utilised in the USA.(171)
2.4.3 Diabetes intervention tool
In order for a tool be effective it has to first allow retrieval and organize information.
Secondly, a healthcare professional should be able to apply his judgement based on
the information to make his decision as suggested by Weed.(177) In a time
constrained outpatient pharmacy, pharmacists should be able to retrieve information
quickly and exercise judgement based on the information presented to make
interventions.(177) Several studies have revealed that healthcare professionals
utilise tools in making treatment choices and in providing patient counselling and
education. A brief summary of intervention tools used in healthcare identified from
a literature search is provided in Table 2.5.
Table 2.5: Evidence-based intervention tools
No. Author, (year)
Name of Tool Country Function of Tool
1. Anthierens 2012(178)
INTRO (internet training for antibiotic use)
Belgium, UK, Poland, Spain, Netherlands
Promote prudent antibiotic prescribing
2. Barry 2007(179)
START (Screening Tool to Alert doctors to the Right Treatment)
Ireland Evidence-based screening tool for indicated medicines in the elderly
3. Basger 2008(180)
Prescribing indicators for elderly
Australia List of medications indicated for elderly based on most frequently prescribed drugs for most frequent disease
4. Joseph 2010(181)
CREDIT (cancer reduction education intervention tool)
USA Computer-based learning to educate patients at risk of Hereditary Breast and Ovarian Cancer (HBOC)
53
No. Author, (year)
Name of Tool Country Function of Tool
5. Litvin 2013(182)
CDSS (clinical decision support system)
USA A tool to improve antibiotic prescribing for acute respiratory infections
6. Nelson 2011(183)
MyRxPad USA Prescribers make prescribing decisions based on personal medication records contributed by patients
7. Paxton 2011 (184)
STC (Starting the conversation)
USA Eight-item simplified food frequency instrument designed for non-dieticians
8. Santo-Novak 2001(185)
MSHAKE (Mary Starke Harper Aging Knowledge Exam)
USA A 25-item tool for measuring knowledge related to geriatric mental health of staff caring for elderly
9. Stein 2013(186)
CommonGround USA Shared decision-making tool on psychotropic medicine adherence
10. Murphy 2012(187)
Signposting, Inhaler technique, Medication review, Peak Flow Expiratory, Lifestyle advice & health promotion and Education (SIMPLE)
UK Each letter represents a component of intervention for asthma patients as recommended by national guidelines.
11. Morisky 2008(188)
The 8-items MMMAS USA Tool to assess patients’ adherence to their medication
12. Miller 1994(189)
Responsibility for change, Advice to change, Menu of treatment options, Empathic style, Self-efficacy of participant (FRAMES)
USA A tool used as intervention method to reduce harm in substance abuse
13. Cameron 2002(190)
Subjective, objective, assessment, plan (SOAP)
USA Format for documentation of patient’s continuity of care
UK= United Kingdom; USA= United States of America
A tool used by physicians and healthcare professionals for record keeping is SOAP, an
acronymn for subjective, objective, assessment and plan where each letter of the
54
word represents a section that is included in the case notes(190). An eight item
intervention tool used to assess dietary patterns entitled starting the conversation
(STC) is a brief validated tool used by non-dieticians in outpatient settings.(184)
Literature search on tools used by pharmacists in the community and primary health
care settings revealed specialised tools for specific population. One tool to detect
potentially inappropriate prescribing for the elderly is the Ghent older people's
prescriptions community-pharmacy screening (GheOP³S) tool. This tool was found
feasible among community pharmacists in Belgium.(191) Pharmacist successfully
detected inappropriate medications among 987 patients. A nine-item questionnaire
measured patients’ perception of their medication by categorising their concerns
using a five-point Likert scale. This tool was found beneficial for pharmacists to
conduct interventions based on patients’ medications concern.(192) In heart failure,
community pharmacists successfully detected patients with worsening heart failure
utilising a six item screening tool for heart failure symptoms named The One Minute
Clinic for heart failure.(193) A simple tool, DOCUMENT, to identify and conduct
clinical interventions among community pharmacists in Australia recorded 5948
MRPs. The tool was found advantageous and was therefore implemented
nationwide.(194) In Australia, a tool to assess risk of T2DM, the AUSDRISK tool, was
found acceptable among pharmacists in the community setting.(195)
Literature searche on available diabetes intervention tools revealed a checklist for
pharmacist to use when conducting diabetes management reviews. It consisted of
88 questions that effectively identified potential drug related problems.(196)
However, there was a lack of published evidence of pharmacists using this checklist
in practice. Nevertheless, a tool to manage T2DM patients with complications which
prompts about their management is lacking and little evidence is offered in the
processes followed by pharmacists to retrieve necessary information in published
diabetes studies. A targeted training incorporating a diabetes intervention tool that
delivers structured and consistent method of intervention will be valuable.
55
2.5 Overall thesis research area
The review of the literature over the last decade has revealed numerous pharmacist
intervention studies on diabetes management. Although most studies showed
improved clinical outcomes, the results were inconsistent, even though the same
factors were addressed, little is known about the process followed by pharmacists to
make diabetes care interventions. This research therefore was aimed to prioritise,
rank and construct validate evidence-based indicators utilised in the management of
T2DM. In addition, it developed a targeted training package on the application of the
tool and explored pharmacists’ perceptions of the tool’s relevance and usefulness in
delivering quality diabetes care. Finally, the research trialed the clinical and QOL
outcomes of patients managed with the tool.
The research has important clinical significance for management of diabetes. The
intention of the tool is to assist pharmacists to provide targeted intervention in a
structured and consistent way. In addition, it is hoped that the research findings of
the tool’s effectiveness will increase the uptake of this tool in MMS services such as
Diabetes MedsCheck in Australia, MTAC Diabetes in Malaysia and MMS service
worldwide.
Specific objectives of each of the three phases are presented in specific chapter
sections: the objectives of Phase One are located in Section 3.2. Objectives of Phases
Two and Three are provided in Sections 4.2 and 5.2 accordingly.
57
3.1 Introduction
Sections of this chapter were published in: Ayadurai S, Sunderland VB, Tee LB,
Hattingh HL. Consensus Validation of Simpler: A Tool to Improve Pharmacist Delivery
of Quality, Evidence-Based Diabetes Care. Curr Diabetes Rev 2017. A link to the paper
is at https://www.ncbi.nlm.nih.gov/pubmed/29243582
The development of the diabetes intervention tool incorporated the validation of the
content and obtaining design input through the Delphi process. The Delphi process
constituted Phase One of this research. The purpose of this chapter is to present the
Delphi process followed by the Delphi process results. The overview provides a brief
introduction of the Delphi process and justification for use in this research. This is
followed by the methods and results sections, presenting findings from the Delphi
questionnaire. Further analysis and limitations are also discussed.
3.1.1 The Delphi process
The Delphi process has been well tested and used to obtain opinions from a group of
experts on particular issues.(197) It includes a series of rounds of written
questionnaires with the purpose of achieving group consensus.(198) The researcher
sets the consensus level or level of agreement in the beginning. Delphi participants
remain anonymous to each other but each participant knows what the other
participants’ scores are as the researcher sends each participant the group’s median
scores. Participants have the option to either keep or revise their answers in light of
the collated responses from the rest of the participants to each question in each
round. The Delphi process is reiterated and the rounds stop once the set level
consensus has been achieved.(199)
The stages of the Delphi process(200) can be summarised as below:
58
1. Selection of panel (respondents) and allocation of identification numbers.
2. Construction and distribution of the first questionnaire (Round 1). Completion
and return of the Round 1 questionnaire.
3. Collation of individual and group scores and categorisation of suggestions.
Construction of second questionnaire (Round 2).
4. Distribution of the second questionnaire (Round 2). Completion and return of
the Round 2 questionnaire.
5. Collation of individual and group scores and categorisation of suggestions.
Construction of the third questionnaire (Round 3) which is similar to the Round
2 questionnaire but with individual and group scores for each suggestion from
Round 2 incorporated.
6. Distribution of the third questionnaire (Round 3). Completion and return of the
Round 3 questionnaire.
7. Recollation of individual and group scores for each suggestion.
8. Possible further rounds of voting and possible request for rationale and
comments for more extreme scores.
9. Achievement of group consensus with calculation of summary statistics:
maximum, minimum, and range of scores for each suggestion.
10. Distribution and use of findings.
3.1.2 Advantages of using the Delphi process
The Delphi process allows people with different opinions to either conform to the
group’s view or keep their views. It can also guide a group to achieve consensus.(198,
200) Several health care studies have used the Delphi process to develop and validate
processes of care (201-203), develop protocols to reduce inappropriate prescribing
(204-206) or to reduce medication errors.(207-209) There have also been instances
where the Delphi process was used to obtain opinions of experts on specific issues
59
like drug addiction problems (210) or food safety hazards.(211) Details of these
studies are summarised in Table 3.1.
Table 3.1: Intervention studies using the Delphi process
Study site No. of participants
No. of Rounds
% set for level of agreement
Type of Intervention
Malta, UK, Ireland (207-209)
12-20 2 70%->80% Identify and develop prescribing indicator to reduce prescribing and medication errors
Taiwan, Northern Ireland, France (179, 204-206)
8-21 2 55% >75% Develop a tool to detect potentially inappropriate medicine among patients
European countries, Australia (201-203, 212)
20
2
>50%
Develop guidance to facilitate process of care
Finland, UK (210, 211)
7-86
3
>75%
Find out experts’ opinion on food safety hazards and changes to the drug addiction problems
60
A literature search found the Delphi process to be a more suitable approach rather than
traditional surveys in studies that involve a need to obtain opinions from experts.(213) The Delphi
process was therefore considered relevant and appropriate for the validation of the Simpler™
tool based on the following reasons:
1. In comparison to traditional surveys that targets the general population who may or may not
be knowledgeable in the subject matter, Delphi process participants include experts who are
knowledgeable and experienced in their field.(213) This was important as the Simpler™ tool
included indicators such as complementary therapies which contained insufficient data to
support their effectiveness in diabetes treatment. Nevertheless, these treatments were still
used in diabetes management and thus required diabetes experts’ viewpoints.(214-216)
2. The Delphi process enabled sharing of experts’ opinions without meeting face-to-face. In
this case, it was impractical for participants to meet due to geographical reasons as
participants were from both Australia and Malaysia.
3. The Delphi process could also be used to rank, prioritize and construct validate the
researcher’s interpretation of indicators in the Simpler™ tool during the Delphi rounds.(213)
4. Delphi participants were anonymous to each other but not to the researcher. Therefore, the
researcher had the opportunity to privately clarify responses that were different from the
group’s responses.
5. In traditional surveys, statistical calculations do not include data from participants who have
missing answers. In contrast, the Delphi process allows researchers to contact participants
regarding the missing answers, as the participant is not anonymous to the researcher.
6. A study on group opinion found it was beneficial for participants to remain anonymous to
each other.(198) Advantages included eliminating influence of dominant individuals and
avoiding situations where an individual may change his/her opinions due to group pressure.
This is particularly useful as participants in the Simpler™ validation tool consisted of various
healthcare professionals who provided different types of care. These included
pharmaceutical care, nursing and medical care.
61
An evaluation of the Delphi process and the literature reporting on its use found it to be a
suitable method to obtain input in the development phase of the Simpler™ tool.
3.2 Objectives
Phase One, the Delphi process, involved collating opinions from a panel of diabetes experts. This
phase of the research aimed to prioritize, rank and construct validate evidence-based indicators
utilised in the management of diabetes. These indicators involved evidence-based
recommendations from the literature and existing diabetes guidelines. Phase One was conducted
between September and December 2014 and had three objectives:
• The first was to determine, using the Delphi process, the order in which the indicators
would appear in the Simpler™ tool hand-out;
• Secondly, to determine additional indicators to be included and
• Thirdly to determine the layout of the Simpler™ tool.
3.3 Method
A detailed account of the steps involved in Phase One of the research are discussed below. This
involved a description of the strategies followed to select potential participants, the construction
of questionnaires, the duration and stability of Delphi rounds and the justification for setting the
level of agreement or consensus.
62
3.3.1 Ethical approval
This study received low-risk Curtin University Human Research Ethics Committee approval (PH-
18-14) shown in Appendix 3.1.
3.3.2 Recruitment of participants
The Delphi process does not require a statistical sample that represents a population. Rather a
group of experts is required to provide input that leads to a decision.(213) The Delphi process
participants were therefore purposively selected as participants who had to be experts in the care
of patients with diabetes with advanced knowledge on diabetes management (217).
In both primary healthcare settings and hospitals, the healthcare professionals with expertise in
medication are mainly endocrinologists, general practitioners, diabetes nurse educators and
pharmacists. These health professionals are involved in the medication management of patients
with diabetes. (4, 10) and were targeted to take part in the process. Apart from these healthcare
professionals, individuals targeted also included doctors specialising in public health who were
involved in developing health policies from academic, government and private sectors.
Participants approached were through personal contacts of researchers. These experts then
nominated other experts and a snowball technique was used to recruit more participants. The
recommended number of participants in a Delphi study ranges between 10 to 15 members (218)
and the recruitment process continued until a sufficient number of participants were recruited.
63
Potential participants from Malaysia and Australia were targeted as the intention was to use the
Simpler™ tool as a diabetes intervention tool in both countries. An electronic mail (email) was
used to personally invite each participant. This followed the suggestion of Turoff and Hiltz who
found that invitation by name rather than a blank invitation increased the likelihood of
participation.(219) In addition, participants were provided with a brief introduction of the
research. The information sheet (Appendix 3.2) and introductory letter (Appendix 3.3) were sent
to participants who agreed to participate.
3.3.3 Development of Simpler™
As previously mentioned in Chapter 2, paragraph 2.2, there are seven factors involved in the
management of T2DM. The factors and indicators for goals of treatment were outlined
particularly in the 2009 Malaysian diabetes guidelines and the more recent 2015 guidelines;
2014/2015 and the recent 2016/2018 Australian diabetes guidelines; the 2014 and later the 2016
American Diabetes Association (ADA) [ADA position statements].(6, 7, 16, 49, 220, 221) The seven
factors are:
1. the use of statin/lipid-regulation medicine
2. the use of insulin and glycaemic control
3. medication adherence and addressing MRPs
4. addressing BP control
5. addressing lifestyle issues
6. providing education and
7. reducing CVD risk
64
By incorporating the first letter of each intervention mentioned above, the acronym SIMPLER was
derived. For the purpose of this and the following chapters, the diabetes intervention tool
developed and evaluated in this research will be referred to as the Simpler™ tool. Figure 3.1 gives
an illustration of the Simpler™ tool derivation.
Figure 3.1: The Simpler acronym derived from letters in the seven diabetes factors
Diabetes Management
SStatin/
cholesterol IInsulin/
Glycaemic
MMedication
PBlood
Pressure
LLifestyle
EEducation
RCVD Risk
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3.3.4 Development of the Delphi questionnaire
The Delphi questionnaire consisted of two sections: Parts 1 and 2 as shown in Appendix 3.4. Each
questionnaire was labelled with a unique code linked to an individual participant. Participants
were asked to provide feedback and suggestions through questionnaires sent through email.
3.3.4.1 Part 1 Delphi Questionnaire
There were seven factors and 29 indicators in Part 1 of the Delphi questionnaire. The sources for
Part 1 indicators in the questionnaire are shown in Table 3.2
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Table 3.2: Reference justification for each indicator of Part 1 questionnaire
Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
Statin
• Statin initiation in patients over age 40 years without CVD Malaysian CPG 2015, Australian CPG 2016/2018
• Statin initiation in patients with CVD
• Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.5mmol/L), TG (<1.5mmol/L).
Australian guideline recommends statins as the first-line choice. Results from literature reviews shows that treatment with statin significantly decreases morbidity and mortality in patients with T2DM and have high cardiovascular risk. The guideline also suggests nicotinic acid, bile-acid resins, ezetimibe and fibrates (fenofibrate, gemfibrozil) as alternatives for people who cannot tolerate statin. Fenofibrate should be considered in patients with diabetes with retinopathy. The goals to reach in cholesterol levels are total cholesterol < 4.0 mmol/L, HDL ≥ 1.0mmol/L, LDL < 2.0mmol/L, TG < 2.0mmol/L.
Malaysian guideline recommends all patients without CVD over the age of 40 years to be treated with statin regardless of baseline LDL cholesterol levels. The target LDL is 2.6mmol/L. Target triglyceride level is <1.7mmol/L. In individuals with overt CVD, statin is also strongly recommended. The target of LDL cholesterol in this population is 1.8mmol/L. The main objective of treatment is to lower LDL. Nicotinic acid is recommended for patients with pancreatitis with TG level more than 10 mmol/L. Combination therapy using simvastatin and ezetimibe has helped to achieve lipid targets.
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Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
Insulin
• Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
• Management of hypoglycaemia
• Self-monitoring of blood glucose
• Target of HbA1c ≤ 7% (53mmol/mol) if no other complications
• Aim 1% reduction of HbA1c
• Initiation/continuation of metformin if no other contraindications
Australian guidelines recommendations for goals of therapy are 6-8 mmol/L fasting and 6-10mmol/L 2 hours postprandial, recommends ongoing self-monitoring blood glucose for those on insulin. However, routine self-monitoring of blood glucose in low risk patients who are using oral anti diabetes medication (except sulphonylureas) is not recommended. HbA1c needs to be individualised but generally should be ≤7% (53 mmol/mol) [range 6.5-7.5 (48-58 mmol/mol)]. Patients with severe hypoglycaemia should raise their glycaemic targets to avoid further hypoglycaemia. Metformin is the first choice if lifestyle modification does not achieve glycaemic control unless contraindicated. While stepwise approach is recommended for the management of T2DM, it however does not match individualised patient needs. Therefore, patients are given a choice on the treatment depending on efficacy, risk of hypoglycaemia, major side effects, weight gain and costs.
Insulin should be initiated in patients who are taking maximum doses of oral hypoglycaemic agents such as metformin and sulphonylureas who have suboptimal glycaemic control or above individualised target of HbA1c either with symptoms or without symptoms of hyperglycaemia. Before starting insulin, ensure that all possible causes of hypoglycaemia such as lifestyle, noncompliance to medications or other medical conditions have been addressed.
HbA1c is recommended to assess long-term blood glucose control. Adjustments to diabetes treatment should be considered if HbA1c target is above 7% (53mmol/mol). Measurement error with HbA1c means a target range of 6.5-8% (48-64 mmol/mol) is acceptable to allow for measurement variation and for individualised approach. Target should be individualised to as low as possible without side effects. HbA1c should be maintained at no lower than 7.5% (59 mmol/mol) depending on life expectancy.
Malaysian guideline outlines the target for glycaemic control is fasting 4.4-6.1mmol/L, and non-fasting is 4.4-8.0 mmol/L. The target HbA1c for newly diagnosed, younger age, patients with low risk of hypoglycaemia is 6.0-6.5% (42-48 mmol/mol), 7.1-8.0% (54-64 mmol/mol) for patients with co-morbidities which is also in line with ADA recommendation, short life expectancy and prone to hypoglycaemia and 6.6-7.0% (49-53 mmol/mol) for the rest.
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Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
Metformin is the preferred choice as first line therapy. If targets are not met after optimal oral anti diabetes therapy, consider adding basal insulin or GLP-1 RA. For patients on insulin, metformin is strongly recommended to be continued indefinitely unless patients develop CKD stage 4 and 5.
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Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
Medication
• Review medication adherence using 8-item MMMAS.(1)
• Assess medicine related problems (pharmacotherapy)
Australian guideline recommends asking about hypoglycaemia or other side effects of medications especially for patient on insulin or sulphonylureas.
Complementary and alternative medicines are not recommended for glycaemic control for patients with diabetes according to Malaysian guideline. The latter also strongly suggests health education, diet therapy, exercise and compliance to medicines to be reinforced at follow up which later outlines the role pharmacist play in ensuring adherence and giving information about medication mode of action and side effects. Also, it includes administration and adjustment of insulin dosing.
To increase medication adherence, the medication therapy management service (MMS) as suggested by Strand and Cipolle is adopted (62). In MMS, each patient’s medications including supplements, traditional, alternative, non-prescription are reviewed. This is to ensure the medicine is appropriate, effective, safe and convenient for the patient to take. If there is medicine related problem, it will be resolved by changing product, doses or by educating the patient effective use of medication. The care plan is developed to achieve goals of therapy and the patient is followed up.
Both MTAC Diabetes and Diabetes MedsCheck recommend using the 8-item MMMAS to assess the medication adherence.
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Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
BP
• BP Target: 130/80 or less
• Reduce sodium
• ACEI/ARB for patients without microalbuminuria/proteinuria
• ACEI/ARB for patients with microalbuminuria/proteinuria
Australian guideline recommends reaching target blood pressure (BP) of 130/80 mmHg and for people with microalbuminuria or macro albuminuria. Target BP≤140/90 mmHg in general or people with CKD. Treatment to lower BP in people with diabetes must include angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB). If monotherapy does not reduce BP, calcium channel blocker or low-dose thiazide or thiazide-like diuretic is recommended.
The Malaysian guideline recommends a reduced sodium intake for normotensive and hypertensive patients. It recommends <2400mg sodium/day or 6g of salt a day or 1 teaspoon). Sodium restriction can be achieved through avoiding high sodium foods, reducing the number of times to eat out and limit salt in cooking to ¼ to ½ teaspoonful of salt per person per day. Further sodium restriction is necessary if patient has nephropathy and BP is not controlled. ACEI or ARB is recommended first line for patients with diabetes and microalbuminuria or proteinuria. Multiple drug therapy such diuretics, calcium channel blockers (CCBs), beta blockers and peripheral alpha blockers are generally required to achieve blood pressure targets. Target BP in patients with diabetes with proteinuria should be ≤130/80 and ≤125/75 in patients with proteinuria. Pharmacological treatment should be initiated in patients with diabetes when the BP is >140mmHg and or >90mmHg and to treat if SBP lower than 135mmHg and DBP lower than 75mmHg.
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Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
Lifestyle
• Alcohol intake ≤2 standard drinks (20g)/day for men and women
• Exercise -30 mins walking (or equivalent) 5 or more days/week
• Smoking Cessation
• Advice on foot care
• Weight loss, BMI<25kg/m2(Australia), BMI <23kg/m2 (Malaysia);
• Achieve waist circumference targets
• Erectile dysfunction- PDE-5 inhibitor as first line therapy
• Management of stress & diabetes related distress
Australian guideline recommends loss of body weight as it can lead to improved glycaemic control, BP and lipid profiles. Weight reduction of approximately 5 kg is associated with an approximate reduction of HbA1c of 0.5-1%. Weight loss of 2-3 kg is associated with a reduction with 4.5mmHg systolic and 3-3.5mmHg diastolic. BMI is different for different ethnic groups. For European descent, BMI is 18.5-24.9, while people of Asian origin, BMI is lower and higher BMI for people with Torres Straits Islander and Maori people.
The therapeutic goal is 5-10% loss for people overweight or obese. For patients with diabetes with BMI>35 and comorbidities or BMI>40, should consider more weight loss.
People with moderate (Framingham risk= 10-15%) and high-risk CVD, (Framingham risk>15%), advice and support regarding diet and physical activity 30 minutes or more on most days of the week (total ≥150minutes/week), smoking cessation as well as education on BP and lipid lowering therapy is recommended.
It also recommends assessing patients at risk of developing foot complications. Full eye review to be conducted every 2 years.
The Malaysian guideline recommends normal range for BMI as 18.5-22.9 kg/m2. Achieve weight loss of between 5 to 10% in 6 months to improve glycaemic control, blood pressure, lipid profile and QOL. Physical activity consisting 250 to 300 minutes per week of exercise. For erectile dysfunction in men the recommended first line treatment is Phosphodiesterase-5 (PDE-5) inhibitors e.g. sildenafil. The problems and concerns that cause distress to the patient need to be addressed as this may affect management of diabetes.
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Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
Education
• Structured education programme include knowledge and understanding of medicine
• Medicine taking and storage during travel
• Medication optimisation during fasting month for Muslims
T2DM patients should be given structured diabetes education either in groups or delivered individually. It should target different cultures and socioeconomically disadvantaged population. This is the recommendation from the Malaysian guideline.
In addition, it recommends diabetes education to all patients with T2DM regardless of treatment mode. The more the duration of contact time between the educator and the patient, the better the A1c reduction. A face to face delivery, reinforcement of education using monthly telephone calls improves glycaemic control and compliance. Malaysian CPG suggests that contents of education should include diet, food exchanges, exercise, medication including timing and dosing, complications, self-care, SMBG, foot care, smoking cessation, problem solving skills e.g. management of hypoglycaemia, sick days and psychosocial adaptation to diabetes. The benefits of achieving glycaemic control for period of time presents benefit in terms of prevention of diabetes complications and this known as legacy effects should be emphasised to all newly diagnosed patients with diabetes. Adjustment of the diet and medication protocol for Ramadan fasting is required. Diabetes treatment should be individualised during fasting. Education on hypoglycaemia, hyperglycaemia and dehydration is emphasised. Patient need to check the blood glucose level before, during and after prolonged physical activity. This is also stressed by the standards of medical care published by American Diabetes Association who recommends to ask individuals at risk for hypoglycaemia about hypoglycaemia like symptoms at every visit.
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Factors and Indicators Excerpts from 2016/2018 Australian, 2015 Malaysian and 2016 American Guidelines(6, 7, 16)
CVD risk
• Aspirin therapy (75mg-162mg/day) as primary prevention strategy at increased CVD risk (10-year risk>10%, Framingham)
• Aspirin therapy as secondary prevention in those with diabetes with history of CVD
• Use of Framingham risk calculator to calculate CVD risk and educate patient
Australian guideline does not recommend aspirin for primary prevention. Intensive antithrombotic therapy is recommended for secondary prevention. Patients with high risk of CVD must be simultaneously treated with lipid and BP lowering treatment and given lifestyle advice.
Malaysian guideline recommends CVD risk calculator such as Framingham risk score (FRS) or Systematic coronary risk evaluation (SCORE) to calculate the CVD risk score. Aspirin is recommended as secondary prevention and primary prevention of CVD with low dose aspirin (100mg) is not recommended in patients unless they are above 65 years. This differs from the previous 2009 Malaysian CPG which recommended aspirin for primary prevention only if they are at high risk using the Framingham risk score.
The USA guidelines recommend aspirin therapy (75-162mg) as a primary prevention strategy among patients at increased cardiovascular risk (10-year risk >10%). This includes men aged >50 years and women aged ≥50years who have at least one additional major risk factor for e.g. family history of CVD, hypertension, smoking, dyslipidaemia, or albuminuria. However, the level of evidence for this recommendation is low.
ADA= American Diabetes Association; ACEI= angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; BMI= body mass index;
BP=blood pressure; CCB= calcium channel blocker; CKD= chronic kidney disease; CVD= cardiovascular disease; CPG= clinical practice guideline;
DBP=diastolic blood pressure; GLP-1RA= glucagon like peptide 1 receptor agonist; HDL= high density lipoprotein; HbA1c=glycated haemoglobin;
LDL= low density lipoprotein; MMMAS= modified Morisky medication adherence scale; MTAC diabetes= medication therapy adherence clinic
diabetes; PDE-5 inhibitor=phosphodiesterase-5 inhibitor; T2DM= Type 2 diabetes mellitus; TG=triglyceride;
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An informed decision was made to include all the 29 indicators in the hand-out as these
indicators were evidence-based factors emphasized in diabetes guidelines from
Australia, Malaysia, Europe, the USA and the UK.(6, 7, 16, 17) However, opinions were
required on the order of importance the indicators should appear in the hand-out. A
score = 1 was ranked as most important and would appear as the first subheading, 2 as
the second subheading which is the second most important indicator, 3 as the third
subheading and so on. Participants were instructed to choose only one number per
subheading. A space was allocated in the questionnaire for the participants to enter
their comments or suggestions. Table 3.3 and Figure 3.2 below gives a clearer illustration
of this procedure.
Several articles from the literature regard pilot testing of Delphi questionnaires as
optional.(222, 223) In this study, test and retest reliability were not conducted as the
questionnaires were validated by three members of the research team who were
knowledgeable in diabetes.
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Table 3.3: Part 1 questionnaire instructions
Code Indicator Name and Description
Appearance of indicator in hand-out in order of importance.
Please choose one number for each indicator. The same number cannot be picked more than once for each of the indicator.
Order of appearance in hand-out
1
1.1 Statin initiation in patients with CVD
□1 2 □ 3 This will be the second bullet point to appear in the hand-out
1.2 Statin initiation in patients over age 40 years without CVD
1 □2 □ 3 This will be the first bullet point.
1.3 Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.5mmol/L), TG (<1.5mmol/L).
□1 □2 3 This will be the third bullet point.
Based on the numbers chosen in the table above, the order of appearance in the hand-
out is as below (Figure 3.2)
Figure 3.2: Order of appearance in hand-out
S
• Statin initiation in patients over age 40 years without CVD
• Statin initiation in patients with CVD
• Achieve targets: LDL, Malaysia (LDL<2.6 mmol/L, TG<1.7 mmol/L) Australia (LDL<2.5 mmol/L), TG (<1.5 mmol/L)
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3.3.4.2 Part 2 Delphi Questionnaire
Part 2 consisted of two indicators on the layout of Simpler™ hand-out and seven
additional indicators on prevention of diabetes complications and treatment
recommendations not included in the 2009 Malaysian guideline.(49) Some of the
recommendations from these additional evidence-based indicators were sourced from
2014 EASD/ADA position statement and 2014/2015 Australian guidelines.(220, 221)
While others were from randomised controlled studies carried out on small cohort
population. As such, a consensus was required for these seven indicators to be included
in the Simpler™ hand-out. Of interest, the recent 2015 diabetes guidelines from
Malaysia (6) included two out of seven of Part 2 indicators of the questionnaire
constructed prior to 2015.
Participants were asked to rate each indicator in terms of its importance in making
diabetes interventions. The score was rated according to a five point Likert-scale where
1 = least important or redundant and 5 =most important, as suggested in Delphi
literature references.(200)
In addition, participants were asked to provide their rationale for choosing a certain
score as well as additional suggestions or interventions apart from that already provided
in the questionnaire. An excerpt of that follows:
A space is provided for you to briefly explain the reason for your rating if you wish to. This
additional information is optional and could help us understand the reasons some indicators
received a more important ranking than others. The space could also be used for additional
suggestions or interventions that should be included according to indicators mentioned.
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The indicators in Part 2 consisted of two questions on Simpler™ hand-out layout and
seven indicators on medication management, lifestyle issues such as diet and sleep
hygiene and annual eye assessment.
There were two choices for the layout. Figure 3.3 and Figure 3.4 shows these choices.
Participants were required to rank using the Likert scale their preferred choice. A score
of 1 denoted least preferred and a score of 5 denoted most preferred.
Figure 3.3: Hand-out of the Simpler™ tool (Bookmark design)
Figure 3.4: Hand-out of the Simpler™ tool (Wheel design)
S
I
M
P
L
E
R
S
I
MP
L
E
R
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Table 3.4 provides the seven indicators, the excerpts and the sources of reference for
each of these indicators.
Table 3.4: Reference justification for seven indicators in Part 2 of the questionnaire
Factors and Indicators Sources of References
Administer once daily antihypertensive at bedtime
Both the 2016 Malaysian and the 2016 ADA guidelines recommend the administration of one or more antihypertensive medications at bedtime. (6, 16)
Diet advice using plate model
Plate model was introduced as a simple way to eat small portions as well as an education tool. Dieticians from Canada, Finland, France, Sweden and now the USA found it to be a better alternative carbohydrate exchange-based method. (224-226)
Annual eye assessment The Australian guidelines recommend eye examination to be carried out once every two years. The Malaysian and the American guidelines recommend annual eye assessment.(6, 16)
Address sleep hygiene The Australian and Malaysian guidelines suggests management of sleep deprivation which can aggravate insulin resistance, hypertension and hyperglycaemia.(6, 7)
1g-3g cinnamon intake per day
Several randomised controlled studies conducted have found the benefits in taking cinnamon especially in the improvement in glycaemic control. The range of dose used in these studies were 1g to 3g in the capsule form.(227-231)
Vitamin B12 supplement in patients on long term metfomin
Although both the current, 2016 Malaysian and the American guidelines acknowledge Vitamin B12 deficiency when on long-term treatment with metformin, clear guidance on taking vitamin B12 was not mentioned.(6, 16)
Encourage daily Intake of tree nuts (almonds, brazil nuts, cashews, hazelnuts, macadamia, pecans, pine nuts, pistachios and walnuts)
Systematic review done found 12 randomised controlled studies on tree nut consumption led to improved glycaemic control.(232) However, consuming tree nuts to improve glycaemic control were not recommended in the Malaysian, Australian, European, the UK or American guidelines.
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3.3.5 The Delphi rounds
3.3.5.1 Delphi round 1
In this round, Part 1 and Part 2 questionnaire were sent to 12 participants recruited
earlier. They were asked to rank Part 1 indicators in the order they should appear in the
Simpler™ hand-out and chose the indicators in Part 2 questionnaire which should be
included in the hand-out.
3.3.5.2 Delphi round 2
At the conclusion of Round 1, three (27%) participants in Part 1 of the questionnaire
chose the same number for more than one sub-indicator for a specific indicator multiple
times despite the detailed instructions provided as indicated in paragraph 3.2.3.
Therefore, in Delphi Round 2, these three participants were sent the same questions as
was in Round 1 but the instructions for questions in Part 1 were rephrased to:
The rest of the participants also received a similar questionnaire to Round 1 and similar
to the questions received by the three participants mentioned above but with separate
instructions as below:
1. In Part 1 of the questionnaire, the same number cannot be picked more than once
for each of the indicators, however you have chosen the same numbers multiple
times for some of the questions. You are given the opportunity in this round to
revise your rankings. The table provides comparison between your score and
median score for the rest of the participants.
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An excerpt of the Round 2 questionnaire is presented in Appendix 3.5.
During Round 2 the second questionnaire was distributed which was similar to the Round
1 questionnaire but in addition it contained scores of individual participants and the
group median scores. The group median scores represented statistically analysed results
of collected opinions from each of the 12 participants. This allowed participants to view
his/her result in relation to the group scores. Participants however did not know other
participants’ individual scores as each participant was only provided with his/her scores
thereby maintaining individual anonymity. A similar process was repeated in Round 3.
Returned Round 2 questionnaires were scrutinised for missing answers and whether the
same answer was chosen multiple times in Part 1 of the questionnaire. Such
questionnaires were sent back to the participants in order for them to complete the
questionnaire.
1. In Part 1 of the questionnaire, the same number cannot be picked more than once
for each of the indicators, however some of the participants have chosen the
same numbers multiple times for some of the questions. In this round, you can
either retain or revise your scores.
2. In Part 2 of the questionnaire, you are asked to either retain your score or revise
it up or down. The table provides a comparison between your score and the
median score for the rest of the participants.
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3.3.5.3 Delphi round 3
Completed Round 2 questionnaires were analysed and group median scores and the
frequency of the answers were calculated using IBM Statistical Package for Social
Sciences (SPSS) software version 22.(233) An excerpt of the dataset in SPSS is shown in
Appendix 3.6. The format of the Round 3 questionnaire was the same as the Round 2
questionnaire (Appendix 3.7). However, it contained an additional instruction, shown
below:
3.3.6 Duration of the Delphi rounds
Participants were given two weeks to complete the questionnaire during Rounds 1 and
2 and one week for Round 3. The overall duration of the Delphi process was three
months. Questionnaires were sent to participants through emails with reminders three
days before due dates. Ongoing reminder emails were sent to participants who were
1. In this round, your score and the group median score is revealed. The indicators
highlighted in yellow shows where your score differs from that of the group score
(median score). The aim of the Delphi process is to achieve consensus on an
indicator and this can only be achieved if more than 60% of participants give the
same answer for each indicator.
2. Participants do not have to revise indicators where consensus was achieved. This
will be indicated in the table below.
3. Participants have the option to revise or retain indicators where their scores are
similar to that of the group score. Bearing in mind, consensus would be harder
to achieve if your scores are not the same as the group score.
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overdue in their responses. The data analysis for each round commenced once all
responses were received. Figure 3.5 represents the flow of the Delphi process.
Figure 3.5: Flow of the Delphi process
3.3.7 Achieving consensus
The goal of the Delphi process is to achieve consensus; that is when participants
unanimously agree on a criteria or issue. In this research, consensus is achieved when
participants agreed on the order the indicators should appear in the Simpler™ hand-out
(Part 1) and on indicators that should be included in the hand-out (Part 2). However, the
literature search indicated lack of guidelines on consensus levels with levels from
previous studies varying between more than 50% (201-203, 212) to more than 80%.
Participants selectionn=12
Questionnaire(Q)development
Round 1-distribution-completion and return
Collation of responsesn=11
Additional recruitment to replace one dropped participant
Analysis of data & construction of Round 2 Q
Round 2-distribution-completion and return
Collation of responsesn=12
Analysis & construction of Round 3 Q
Round 3-distribution-completion and return
Collation of responses
Consensus achieved after statistical analysis
No further rounds
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(209) However, this is in agreement with a review study which states that more than a
50% level of agreement constitutes a majority and successive rounds should cease at this
point.(199) For the purpose of this research, a consensus level of more than 60% was
set, as suggested by Stitt-Gohdes,W.(234) This meant, consensus was reached if more
than 60% of participants ranked the indicators with the same score. Median rather than
mean was chosen to represent the group scores as median can be used to establish the
central tendency in the Delphi process.(235)
In Part 2 of the questionnaire, consensus agreement criteria was when more than 60%
of the participants rated each indicator’s score = 4 or 5. In one study the author defined
a score of = 4 or more in a 7-point rating scale as a high level of agreement.(200) The
justification for this is that a score of 4 or more falls in the upper quartile range in a 7-
point Likert scale. In a 5-point Likert scale the upper quartile range includes scores of 4
and 5. For the purpose of this research, an indicator in Part 2 of the questionnaire had
to receive a score of 4 or 5 from more than 60% of participants in order to be included
in the hand-out.
3.3.8 Stability of the rounds
Stability is described as consistency in responses between two rounds.(199) However,
Delphi studies do not define a definite method to measure stability. This resulted in
some studies using both stability and agreement criteria as necessary to determine if
further rounds should continue (199, 213, 236), while others concluded that either
stability or consensus should be the determining factor in continuing the rounds.(235)
The majority of the Delphi studies done recently suggested achieving consensus as the
sole reason for terminating the rounds.(179, 201, 203-212) In the absence of a standard
84
method to measure stability, it was decided that the criteria to stop further rounds
should depend solely on achieving the predetermined consensus level.
3.4 Results
In the following section, the results of the Round 1 questionnaire are presented followed
by construction of the Round 2 questionnaire based on the Round 1 results. The findings
from Round 2 and construction of Round 3 questionnaire are subsequently presented.
The final section provides the results of the changes in rankings between Rounds 2 and
3 and between and the consensus level for each of the questions in Round 3.
3.4.1 Participants
Twelve participants agreed to take part in Round 1, however only 11 responded. In
Round 2, an additional participant was recruited to account for the Round 1 non-
respondent. Hence, the total number of Round 2 participants was 12. Both Rounds 2
and 3 produced 100% response rates. Table 3.5 is a summary of the participants’ areas
of expertise and workplace.
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Table 3.5: Breakdown of Delphi process participants (n=13)
Practitioner Country Practice
Malaysia Australia Public Private
Primary health care pharmacist,
(Klinik Kesihatan Mahmoodiah), Johor
Clinical pharmacist (hospital) Hospital Pulau Pinang
Clinical pharmacist (Administration)
Pharmaceutical Services Division, Malaysia
Consultant endocrinologist Hospital Sultanah Aminah, Johor
Public health physician, Disease Control Division, Department of Public Health, Malaysia
Family medicine specialist, Johor
General practitioner, Johor
Academic pharmacist, Perth
Community pharmacist (diabetes educator), Perth
Community pharmacist (multiple chain stores), Perth (dropped out in Round 1)
Endocrinologist, Hollywood Hospital, Perth
General practitioner, Perth
Diabetes nurse educator, Hollywood Hospital, Perth
Total 7 5 6 6
3.4.2 Delphi round 1
In round 1, 11 of the 12 participants responded. In addition, not all questions received
a 100% response rates. Although the percentage of participants who answered the
questions were high (80%), this however, had the potential to influence the consensus
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level as documented in a previous study(218). Therefore a 100% response rate was
aimed for all questions. Table 3.6 shows the number and percentages of participants
who answered those questions.
Table 3.6: Indicators which participants missed answering
Questions No. answered Total participants % participants
responded
Part 1
Lifestyle 5.7 10 11 90.9
Part 2
Additional 9.5 10 11 90.9
Additional 9.7 9 11 81.8
One participant pointed out that medication optimisation during fasting month for
Muslims also applies to other religious groups (Part 1, question 6.3). Another participant
required more information on addressing sleep hygiene (Part 2, question 6.3). The
results of Round 1 Part 1 of the questionnaire are shown in Table 3.7. The results are
presented in the same format as reported in Delphi literature.(200, 234) Similarly,
results for Part 2 of the questionnaire are presented in Table 3.8.
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Table 3.7: Results of Round 1 Part 1
No Part 1 Indicators Round 1 (n=11)
#Median *Mode No.participants (% Consensus)
Statin
1. Statin initiation in patients over age 40 years without CVD
1 1 8 (72.7)
2. Statin initiation in patients with CVD 3 3 11 (100)
3.
Achieve targets: LDL, Malaysia
(LDL<2.6mmol/L, TG<1.7mmol/L)
Australia (LDL<2.0mmol/L), TG
(<2.0mmol/L)
2 1 9 (81.8)
Insulin/Glycaemic Control
4. Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
4 1 7 (63.64)
5. Management of hypoglycaemia 3 6 6 (54.6)
6. Self-monitoring of blood glucose to achieve targets
3 5 7 (63.6)
7. Target of HbA1c ≤ 7% (53mmol/mol) if no other complications
2 1,2 6 (54.6)
8. Aim 1% reduction of HbA1c 4 6 6 (54.6)
9. Initiation of metformin if no other contraindications
3 1 6 (54.6)
Medication
10. Review medication adherence 2 2 11 (100)
11. Assess medication-related problems (pharmacotherapy)
1 1 9 (81.8)
Blood Pressure
12. BP Target: 130/80 or less 1 1 8 (72.7)
13. Reduce sodium 3 4 6 (54.6)
14. ACEI/ARB initiation in patients without microalbuminuria/proteinuria
3 3 8 (72.7)
15. ACEI/ARB initiation in patients with microalbuminuria/proteinuria
2 2 7 (63.6)
Lifestyle
16. Moderate alcohol intake ≤2 standard drinks (20g) per day for men and women
5 5 9 (81.8)
17. Exercise-30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
2 1,2 8 (72.7)
18. Smoking cessation 2 1 6 (54.6)
19. Advice on foot care 6 6 9 (81.8)
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No Part 1 Indicators Round 1 (n=11)
#Median *Mode No.participants (% Consensus)
20. Weight loss targets 3 4 6 (54.6)
21. Waist circumference targets 4 1,2,5 6 (54.6)
22. Erectile dysfunction-recommend PDE-5 inhibitor as first line therapy for male patients
6 8 5 (50)
23. Management of stress & diabetes related distress
7 7 9 (81.8)
Education
24. Structured education program include knowledge and understanding of medicine
1 1 8 (72.7)
25. Medicine storage 2 2 9 (81.8)
26. Medication optimisation during fasting month for muslims and other religious groups
3 3 11 (100)
CVD Risk
27.
Aspirin therapy (75mg-162mg/day) as primary prevention strategy at increased CVD risk (10 year risk>10%, Framingham)
2 2 6 (54.5)
28. Aspirin therapy as secondary prevention in those with diabetes with history of CVD
1 1 6 (54.6)
29. Use of Framingham risk calculatorto calculate CVD risk and educate patient
2 1 7 (63.6)
#Median denotes the score lying at midpoint of scores chosen by participants *Mode denotes the score that was chosen most frequently ACEI= angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; BP=blood pressure; CVD=cardiovascular disease; FRS=Framingham risk score; HbA1c=glycated haemoglobin; LDL=low density lipoprotein; PDE-5 inhibitor=phosphodiesterase-5 inhibitor; TG=triglyceride;
The following comments were provided for those indicators that were ranked the least
important in Part 1 of the questionnaire:
Indicator 27: Aspirin therapy (75mg-162mg/day) as primary prevention strategy at
increased CVD risk (10 year risk>10%, Framingham):
‘This is controversial in primary care’ (P7)
89
Indicator 8: Aim 1% reduction of HbA1c:
Indicator 9: Initiation of metformin if no other contraindications:
Table 3.8: Results of Round 1 Part 2
No
Part 2 Indicators
Round 1 Results (n=11)
#Median *Mode +Min ^Max No.participants (% Consensus)
30 Appendix 3a (bookmark design)
4 5 1 5 7 (58.3)
31 Appendix 3b (wheel design)
3 3 1 5 7 (63.6)
32 Administer once daily antihypertensive at bedtime
3 3 2 5 8 (72.7)
33 Diet advice using plate model
4 5 1 5 6 (54.6)
34 Annual eye assessment 4 4 1 5 7 (63.6)
35 Address sleep hygiene 4 4 1 5 9 (81.8)
36 1g-3g cinnamon intake per day
2.5 1 1 5 5 (50)
37 Vitamin B12 supplement with metfomin
3 1,4 1 5 6 (54.6)
38 Encourage daily intake of tree nuts
3 3 1 5 8 (88.9)
#Median denotes the score lying at midpoint of scores chosen by participants *Mode denotes the score that is chosen most frequently +Min denotes the lowest score chosen by participants ^Max denotes the highest score chosen by participants
‘If very high on insulin initiation’ (P12)
‘If considering metformin when initiating insulin…it should be
done well before initiating insulin’ (P12)
90
The following comments were provided for those indicators that were ranked the least
important in Part 2 of the questionnaire:
Indicator 32: Administer once daily antihypertensive at bedtime:
Indicator 36:1 g-3 g cinnamon intake per day:
Indicator 37:Vitamin B12 supplement with metfomin:
Indicator 38: Encourage daily Intake of tree nuts (almonds, brazil nuts, cashews,
hazelnuts, macadamia, pecans, pine nuts, pistachios and walnuts):
‘Sometimes multiple drugs needed’ (P12)
‘Some proof’ (P12)
‘I see that you have references to show/support the use of cinnamon, however
I have not personally seen that being recommended in practice for this
purpose’ (P2)
‘Although long term use of metformin may be associated with B12 deficiency,
it is not a routine recommendation in Australia to supplement patients who
are on metformin (most of them will be on long term) with B12 unless lab
results show low B12 levels or if patient also has other risk factors for example
on long term PPIs [proton pump inhibitors] or have macrocytic anaemia’ (P2)
‘Some proof’ (P12)
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3.4.3 Delphi round 2
Findings from Round 2 Part 1 of the questionnaire is presented in Table 3.9 and Part 2 in
Table 3.10.
Table 3.9: Results of Round 2 Part 1
No Part 1 Indicators
Round 2 (n=12)
#Median *Mode No.participants (% Consensus)
Statin
1. Statin initiation in patients over age 40 years without CVD
1 1 7 (58.3)
2. Statin initiation in patients with CVD 3 3 12 (100)
3.
Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.0mmol/L), TG (<2.0mmol/L)
2 2 11 (91.7)
Insulin/Glycaemic control
4. Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
2 1 6 (54.6)
5. Management of hypoglycaemia 3 3 7 (58.3)
6. Self-monitoring of blood glucose to achieve targets
4 4 7 (58.3)
7. Target of HbA1c ≤ 7% (53mmol/mol) if no other complications
2.5 2 6 (50)
8. Aim 1% reduction of HbA1c 5 6 7 (58.3)
9. Initiation of metformin if no other contraindications
2.5 1,2,6 6 (50)
Medication
10. Review medication adherence 2 2 11 (100)
11. Assess medication-related problems (pharmacotherapy)
1 1 11 (91.7)
Blood Pressure
12. BP target: 130/80 or less 1.5 1 6 (50)
13. Reduce sodium 4 4 12 (100)
14. ACEI/ARB initiation in patients without microalbuminuria/ proteinuria
3 4 7 (58.3)
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No Part 1 Indicators
Round 2 (n=12)
#Median *Mode No.participants (% Consensus)
15. ACEI/ARB initiation in patients with microalbuminuria/ proteinuria
2 1 9 (75)
Lifestyle
16. Moderate alcohol intake ≤2 standard drinks (20g) per day for men and women
5 5 8 (66.7)
17. Exercise:30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
2 2 7 (58.3)
18. Smoking cessation 3 2,3 8 (66.7)
19. Advice on foot care 5.5 3 6 (50)
20. Weight loss targets 2.5 1,4 6 (50)
21. Waist circumference targets 4 1,4 7 (58.3)
22. Erectile dysfunction-recommend PDE-5 inhibitor as first line therapy for male patients
7.5 8 6 (50)
23. Management of stress& diabetes related distress
6 7 7 (58.3)
Education
24. Structured education programme include knowledge and understanding of medicine
1 1 10 (83.3)
25. Medicine storage 2 2 10 (83.3)
26. Medication optimisation during fasting month for muslims and other religious groups
3 3 11 (100)
CVD Risk
27. Aspirin therapy (75mg-162mg/day) as primary prevention strategy at increased CVD risk (10 year risk>10%, Framingham)
2.5 2,3 6 (50)
28. Aspirin therapy as secondary prevention in those with diabetes with history of CVD
1 1 7 (58.3)
29. Use of FRS calculator to calculate CVD risk and educate patient
2 1 8 (66.7)
#Median denotes the score lying at midpoint of scores chosen by participants *Mode denotes the score that was chosen most frequently ACEI= angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; BP=blood pressure; CVD=cardiovascular disease; FRS=Framingham risk score; HbA1c=glycated haemoglobin; LDL=low density lipoprotein; PDE-5 inhibitor=phosphodiesterase-5 inhibitor; TG=triglyceride;
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Table 3.10: Results of Round 2 Part 2
#Median denotes the score lying at midpoint of scores chosen by participants *Mode denotes the score that is chosen most frequently +Min denotes the lowest score chosen by participants ^Max denotes the highest score chosen by participants
3.4.4 Delphi round 3
All 12 participants completed the Round 3 questionnaire. Incomplete questionnaire
were returned to participant concerned to obtain missing answers. Table 3.11 presents
the results of Round 3 Part 1 of the questionnaire.
No
Part 2 Indicators
Round 2 Results (n=12)
#Median *Mode +Min ^Max No.participants (% Consensus)
30. Appendix 3a (bookmark design)
3.5 5 1 5 6 (50)
31. Appendix 3b (wheel design)
3 3,5 1 5 7 (58.3)
32. Administer once daily antihypertensive at bedtime
3 3 1 5 8 (66.7)
33. Diet advice using plate model
4 5 1 5 7 (58.3)
34. Annual eye assessment
4 4,5 2 5 8 (66.7)
35. Address sleep hygiene 4 5 1 5 8 (66.7)
36. 1g-3g cinnamon intake per day
1.5 1 1 5 6 (50)
37. Vitamin B12 supplement with metfomin
2.5 1 1 5 6 (50)
38. Encourage daily intake of tree nuts
3 3 1 5 11 (91.7)
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Table 3.11: Results of Round 3 Part 1
No Part 1 Indicators Round 3 (n=12)
#Median *Mode Number (%Consensus)
Statin
1. Statin initiation in patients with CVD 1 1 12 (100)
2. Statin initiation in patients over age 40 years without CVD
3 3 12 (100)
3. Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.0mmol/L), TG (<2.0mmol/L)
2 2 12 (100)
Insulin/Glycaemic Control
4. Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
1 1 10 (83.3)
5. Management of hypoglycaemia 3 3 10 (83.3)
6. Self-monitoring of blood glucose to achieve targets
4 4 10 (83.3)
7. Target of HbA1c ≤ 7% (53mmol/mol) if no other complications
2 2 10 (83.3)
8. Aim 1% reduction of HbA1c 5 5 8 (66.7)
9. Initiation of metformin if no other contraindications
5.5 6 6 (50)
Medication
10. Review medication adherence 2 2 11 (91.7)
11. Assess medicine related problems (pharmacotherapy)
1 1 11 (91.7)
Blood Pressure
12. BP Target: 130/80 or less 1 1 10 (83.3)
13. Reduce sodium (<2400mg sodium/day (6g salt/day)
4 4 11 (91.7)
14. ACEI/ARB initiation in patients without microalbuminuria/proteinuria
3 3 10 (83.3)
15. ACEI/ARB initiation in patients with microalbuminuria/proteinuria
2 2 8 (66.7)
Lifestyle
16. Moderate alcohol intake ≤2 standard drinks (20g) per day for men and women
5 5 9 (75)
17. Exercise-30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
1 1 9 (75)
18. Smoking Cessation 3 3 10 (83.3)
19. Advice on foot care 8 8 7 (58.3)
20. Weight loss targets 2 2 9 (75)
21. Waist circumference targets 4 4 11 (91.7)
95
No Part 1 Indicators Round 3 (n=12)
#Median *Mode Number (%Consensus)
22.
Erectile dysfunction-recommend PDE-5 inhibitor as first line therapy for male patients
7 7 9 (75)
23. Management of stress & diabetes related distress
6 6 10 (83.3)
Education
24. Knowledge and understanding of medicine 1 1 12 (100)
25. Medicine storage 2 2 12 (100)
26.
Medication optimisation during fasting month for muslims and other religious groups
3 3 12 (100)
Cardiovascular Risk
27.
Aspirin therapy (75mg-162mg/day) as primary prevention strategy at increased CVD risk (10 year risk>10%, Framingham)
3 3 11 (91.7)
28. Aspirin therapy as secondary prevention in those with diabetes with history of CVD
1 1 10 (83.3)
29. Use of Framingham risk calculator to calculate CVD risk and educate patient
2 2 10 (83.3)
#Median denotes the score lying at midpoint of scores chosen by participants *Mode denotes the score that was chosen most frequently ACEI= angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; BP=blood pressure; CVD=cardiovascular disease; FRS=Framingham risk score; HbA1c=glycated haemoglobin; LDL=low density lipoprotein; PDE-5 inhibitor=phosphodiesterase-5 inhibitor; TG=triglyceride;
96
In Part 1 of the questionnaire, two indicators (highlighted in red at Table 3.11) namely
indicator number 9 Initiation/continuation of metformin if no other contraindications
under glycaemic control/insulin factor and indicator number 19 Advice on Foot care
under lifestyle factor had consensus levels of less than 60%. As explained in the methods
section, participants were asked to choose a number (depending on the number of
indicators) to appear in the Simpler™ tool in order of importance with number one being
the most important and two being the second most important and henceforth. As the
rest of the indicators under insulin/glycaemic control factor and lifestyle factor have
achieved consensus on the numbers selected ranked in the order of importance by the
participants, the last remaining numbers not chosen was therefore allocated to these
questions. These process is clarified in the following paragraphs.
Under glycaemic control/insulin factor, there were six indicators thus participants were
asked to rank the order of importance from one to six, one being the most important
and six being the least important. Indicator 9 only received a 50% consensus whereas
indicators 4, 5 to 8 achieved more than 60% consensus on the order of importance they
should appear in the hand-out. There were each ranked one, two, three, four and five.
The only number left out by most participants to rank the indicators under insulin was
number six. Therefore, this number was allocated to indicator 9. Figure 3.6 further
illustrates this process.
97
Figure 3.6: Clarification of allocation of numbers for indicator 9 under glycaemic
control/insulin factors
Under the lifestyle factor, there were eight indicators thus; participants were asked to
rank the order of importance from numbers one to eight. One being most important
and eight being least important. Indicator number 19 only achieved a consensus level of
58.3% less than the 60% consensus level set at the beginning of the study. The rest of
the indicators, namely indicators 16, 17, 18, 20-23, all achieved more than 60%
consensus and they were ranked with numbers 1, 2, 3,4,5,6 and 7. The only number not
selected by majority of participants to rank the indicators under the lifestyle factor was
number 8, thus this number was allocated to question 19. This process is presented in
Figure 3.7.
Glycaemic control/insulin
• 6 indicators
• Need to be ranked from No.1 to No.6 in descending order of importance
Results
• 5 out of 6 indicators achieved consensus: No1, 2, 3, 4 and 5
• Number 6 was not selected by the majority
Action
• Indicator that did not achieve consensus was Question 9 of the questionnaire
• Number 6 was allocated to Question 9
98
Figure 3.7: Clarification of allocation of numbers for indicator 19 under lifestyle
factors
Table 3.12 presents the results of Part 2 of the questionnaire. Only questions with a
median of 4 or 5 were selected to be included in the hand-out. These questions were
grouped together under ‘lifestyle’. Regarding the format of the hand-out the consensus
was the bookmark design, as represented in Figure 3.3 rather than the Figure 3.4 wheel
design. The bookmark design obtained a median score of 4 compared to the wheel
design which received a median score of 3. Three out of seven indicators obtained
consensus on the highest level of the Likert scale (4 or 5). The three indicators are as
follows:
1. Diet advice using plate model
2. Annual eye assessment
3. Address sleep hygiene
There was a need for a detailed explanation on sleep hygiene during Round 1. Therefore,
users were signposted to information on sleep hygiene. However, there were four
indicators which received low rankings. Those indicators are as follows:
Lifestyle
• 8 indicators
• Need to be ranked from No.1 to No.8 in descending order of importance
Results
• 7 out of 8 indicators achieved consensus on numbers 1,2,3,4,5,6 and 7
• Number 8 was not selected by the majority
Action
• Indicator that did not achieve consensus was Question 19 of the questionnaire
• Number 8 was allocated to Question 19
99
1. Administer once daily antihypertensive at bedtime
2. 1g-3g cinnamon intake per day
3. Vitamin B12 supplement with metfomin
4. Encourage daily intake of tree nuts
Table 3.12: Results of Round 3 Part 2
No
Part 2 Indicators
Round 3 Results (n=12)
#Median *Mode +Min ^Max No.participants (% Consensus)
30 Appendix 3a (bookmark design)
4 4 3 5 9 (75)
31 Appendix 3b (wheel design)
3 3 1 5 9 (75)
32 Administer once daily antihypertensive at bedtime
3 3 3 4 11 (91.7)
33 Diet advice using plate model
4 4 4 5 12 (100)
34 Annual eye assessment 4 4 4 5 12 (100)
35 Address sleep hygiene 4 4 1 5 11 (91.7)
36 1g-3g cinnamon intake per day
1 1 1 3 9 (75)
37 Vitamin B12 supplement with metfomin
2 2 1 4 8 (66.7)
38 Encourage daily intake of tree nuts
3 3 2 3 11 (91.7)
#Median denotes the score lying at midpoint of scores chosen by participants *Mode denotes the score that is chosen most frequently +Min denotes the lowest score chosen by participants ^Max denotes the highest score chosen by participants
Based on the findings from the Delphi process, the final order of Parts 1 and 2 indicators
is shown in Table 3.13. Each indicator appears in the same order as chosen by the Delphi
participants. The predetermined consensus level for this research was set at 60% and
36/38 (94.7%) indicators achieved consensus at this level.
100
Table 3.13: The order of appearance of indicators in Simpler™ hand-out based on
outcomes from the Delphi interview
Factors Indicator
Statin • Statin initiation in patients with CVD • Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L)
Australia (LDL<2.0mmol/L), TG (<2.0mmol/L) • Statin initiation in patients over age 40 years without CVD and has
one or more CVD risk factors
Insulin/Glycaemic control
• Insulin initiation if glycemic control not achieved despite being on two or more oral hypoglycemic agents
• Target of HbA1c ≤ 7% (53mmol/mol) if no other complications • Management of hypoglycaemia • Self-monitoring of blood glucose Australia (4.0-6.0mmol/L fasting);
Malaysia (4.4-7.0mmol/L fasting); ; Australia (8-10mmol/L, 2h postprandial). Malaysia (6-8mmol/L-2h postprandial)
• Aim a reduction of 1% HbA1c • Initiate/continue metformin if not contraindicated
Medication • Assess medication-related problems • Review medication adherence using 8-item MMMAS
Blood Pressure • BP target: ≤130/80 • ACEI/ARB initiation in patients with or without
microalbuminuria/proteinuria • Reduce sodium intake
Lifestyle • Exercise: 30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
• Weight loss: Australia (BMI<25kg/m2 ) • Malaysia (BMI <23kg/m2) • Smoking cessation • Waist circumference Australia (<94cm in men,<80cm in women,
waist circumference), Malaysia ( ≤90cm in men,≤80cm in women) • Moderate alcohol intake: ≤2 standard drinks (20g) per day for men
and women with max 4 standard drinks on any occasion • Management of stress& diabetes related distress • Erectile dysfunction: recommend PDE-5 inhibitor as first line
therapy for male patients • Foot care • Diet advice using plate model • Annual eye assessment • Address sleep hygiene
Education • Knowledge and understanding of medicine • Medicine storage • Medication optimisation during fasting month for Muslims and
other religious groups
101
Factors Indicator
CVD risk • Aspirin therapy as secondary prevention in those with diabetes with history of CVD
• Use of Framingham risk calculator to calculate CVD risk and educate patient
• Aspirin therapy (75mg-162mg/day) as primary prevention to decrease CVD risk (10 year risk>10%, Framingham)
ACEI= angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; BP=blood pressure; CVD=cardiovascular disease; FRS=Framingham risk score; HbA1c=glycated haemoglobin; LDL=low density lipoprotein; PDE-5 inhibitor=phosphodiesterase-5 inhibitor; TG=triglyceride;
This section presented the results and briefly examined some of the reasons why an
indicator was ranked a certain score. The following section will discuss possible
explanations on the difference of opinions and potential reasons why certain indicators
were not ranked as important as initially predicted.
102
3.5 Discussion
Phase One of the study was designed to construct and validate the contents of the
Simpler™ tool as a management tool for diabetes mellitus. Phase One also aimed to
determine the layout of the Simpler™ tool. The validation process followed has also
been used in similar published studies.(179, 204-209) However, this will be the first
published research to use the Delphi process involving diabetes experts from both
Malaysia and Australia in the development of a diabetes intervention tool.
The effectiveness of using letters from an acronym to represent an intervention has been
utilised in healthcare delivery for disease management such as:
• Asthma management through the SIMPLE tool that represents signposting,
inhaler technique, Medication Review, Peak expiratory flow reading, lifestyle
advice and health promotion and education.(187),
• Reducing harm in substance abuse through the FRAMES tool, which stands for
feedback, responsibility, advice, menu, empathic, self-efficacy.(189) and
• In first aid treatment for injury through the RICE tool, which represents rest,
icepacks, compression bandages and elevate.(237)
The decision to develop the Simpler™ tool was based on the premise that diabetes is a
complicated disease and there are multiple factors involved in the management of
diabetes. The Simpler™ tool aims to prompt health professionals to retrieve information
quickly through a structured process that assists with organising of the information to
formulate an intervention. The Simpler™ tool summarises seven fields of evidence-
based factors from diabetes guidelines in delivering diabetes care namely cholesterol,
glycaemic and BP control, medication, lifestyle, CVD risk management and provision of
103
education. Each letter of the Simpler™ tool acronym represents those seven individual
factors. Although the indicators in the Simpler™ tool were based on widely published
evidence, yet in terms of importance, the expert participants ranked certain indicators
more important in diabetes management than others. The paragraphs below will
postulate on the possible reasons under the separate factors.
3.5.1 Cholesterol control
Participants ranked statin initiation in patients with CVD as the most important, and this
indicator was also strongly recommended in CPG from both Australia and Malaysia.
Statin initiation in patients over age 40 years without CVD was ranked least important.
This could be due to different recommendations from different CPG. While the
Malaysian CPG recommends statin to be initiated in patients with diabetes over the age
of 40 years regardless of baseline lipid levels, the Australian and American guidelines
have slightly different recommendations. Recent Australian guidelines suggest initiation
of a statin only on cardiovascular risk assessment regardless of age.(7) The 2016
American Diabetes Association Standards of Care recommendations, however, are to
add statin therapy for patients with diabetes who are over the age of 40 years and have
one or more CVD risk factors such as hypertension or a family history of CVD.(16) Both
the Australian and American guidelines were published after concerns of poor glycaemic
control with statin use.
3.5.2 Insulin/glycaemic control
104
The majority of the participants ranked the indicator: aim a reduction of HbA1c the least
important. This could be because insulin targets are individualised and patients suffering
from frequent hypoglycaemia or with multiple comorbidities would be at risk of further
complications if aiming for a stringent target. This is in agreement with the ACCORD,
ADVANCE, DCCT and VADT trials.(27-30)
There was uncertainty among the participants in ranking the indicator: Initiation of
metformin if no other contraindications. The phrase initiation of metformin… caused
some participants to rank it the least important as they indicated that metformin should
be started first before initiating insulin. This is in agreement with diabetes CPG from
Australia, Malaysia, the UK and the USA which emphasis metformin as first line agent for
T2DM and strongly recommends continuing metformin even though the patient is on
insulin.(6, 7, 16, 17) Therefore, the phrase Initiation of metformin if no other
contraindications is changed to Initiate/continue metformin if not contraindicated.
3.5.3 Medication management
The indicator: Assess medication-related problems was ranked more important than the
indicator: Review medication adherence using 8-items MMMAS. One reason could be
that medication non-adherence is a MRP. This is also clarified in the Pharmaceutical Care
Network Europe classification system and in previous studies where non-adherence is
categorised as a MRP.(62, 238)
105
3.5.4 BP control
The observed importance on BP target: ≤130/80 mmHg as more important than other
indicators could be attributed to overwhelming evidence that achieving the BP target
can reduce morbidity. This evidence originates from both the UKPDS and the ACCORD
trials.(26, 30) However, the target level for BP varies between the guidelines. The
2016/2018 Australian guidelines recommend target of ≤130/80 mmHg while the recent
2015 Malaysian CPG recommends <135/75 mmHg.(6, 7) The 2016 ADA Standards of
Medical Care in Diabetes recommends <140/90 mmHg.(16) Due to changes in BP goals,
the targets in the Simpler™ were ammended to follow the recent Malaysian CPG. In
addition, Malaysian CPG recommends salt restriction in normotensive and hypertensive
patients with diabetes to <2400 mg sodium/day or 6g of salt a day or 1 teaspoon. Salt in
cooking is limited to a daily of ¼ to ½ teaspoonful for each person.(6)
3.5.5 Lifestyle
Exercise was rated more important than the other indicators in the lifestyle factor. A
possible explanation for this might be due to compelling evidence on benefits of exercise
in diabetes management.(239-244)
While most of the lifestyle indicators from Part 1 of the questionnaire were based on
CPG from both Australia and Malaysia, the indicators from Part 2 were from published
clinical trials. Surprisingly, the majority of participants did not rank the indicators as
being important. Comments from participants suggest insufficient studies to support the
safety and efficacy of these recommendations. The participants’ comments seemed to
106
be consistent with studies indicating a need for trials that are larger and of longer
duration.(227, 245)
For instance, the first indicator that did not score well on the Likert scale was indicator:
Administer once daily antihypertensive at bedtime despite graded as the highest level of
evidence in ADA standards of medical care which suggests to “administer one or more
antihypertensives at bedtime”.(16, 246) This bedtime recommendation is based on
studies which found dosing of antihypertensives reduced CVD events and achieved
better BP control.(247, 248). Six trials were conducted among hypertensive patients who
had diabetes or Chronic Kidney Disease. However, the number of trials do not reflect a
diverse population. Additionally, the class of antihypertensive medicine that should be
taken at bedtime were not studied. However, the more recent 2015 Malaysia Guidelines
and 2016 ADA Standards of medical Care in diabetes recommend one or more
antihypertensive medicine to be taken at bedtime. Both these guidelines grade this
recommendations with the highest level of evidence.(6, 16) Based on this, the research
team decided to include the indicator, one or more antihypertensive medicine to be taken
at bedtime into the Simpler™ tool.
The second indicator that the panel of experts did not chose to be included in Simpler™
tool was indicator: 1g-3g cinnamon intake per day to improve glycaemic control. This
seem to be consistent with data obtained from a few randomised clinical trials which,
although they have shown cinnamon to be effective in improving fasting blood glucose
levels, the limitations in the these studies do not warrant the use of cinnamon in practice
settings.(227-231) This is mainly because cinnamon doses and the formulations used in
the trials varied and long-term effects are not known.
The third indicator which did not achieve concensus was the need to take Vitamin B12
supplement in patients on long term metfomin. Studies conducted in the Netherlands,
107
India, and the USA found evidence of vitamin B12 deficiency among patients on long
term metformin.(245, 249, 250). Although these studies strongly suggest Vitamin B12
supplementation, long term large trials on the effectiveness of Vitamin B supplements in
these patients are lacking.
The final indicator not selected was the daily intake of tree nuts (almonds, brazil nuts,
cashews, hazelnuts, macadamia, pecans, pine nuts, pistachios and walnuts). A
systematic review and meta analysis of 12 RCTs showed an association of tree nuts with
significant improvement of HbA1c.(232) However the authors found inconsistencies in
the studies and concluded that there was a need for larger trials that show evidence of
long term effects.
3.5.6 Education
Patients with diabetes ranked “knowledge and understanding of medicine” to be most
important. Several RCTs have shown that education alone can decrease HbA1c by 1%
and simultaneously improve medication adherence.(124, 251-256) The need to have a
structured education process to create awareness patients are, to some extent,
addressed by diabetes nurse educators in Australia and in Malaysia. In comparison to
pharmacists, they are not easily accessible as there is a need to be referred by a GP in
both countries in the primary healthcare setting. Community pharmacists, on the other
hand, are easily accessible with extended opening hours, therefore provision of diabetes
services through pharmacies could enable more patients to be able to receive education.
In the DMAS program conducted among 90 community pharmacies in Australia, it found
pharmacists were equally competent to educate patients to self-manage and
consequently contribute to better health outcomes.(257)
108
Education is also important in self-management of patients with diabetes during the
fasting month for Muslims, Ramadan, and in other religious groups. Patients who were
given education on disease management and their medications were found to have less
weight gain and hypoglycaemia episodes.(258) Education tailored to these patient
demographics has shown to clarify certain issues believed by some that drawing blood
and insulin injections would nullify the fast.(259)
3.5.7 CVD risk factors
“Aspirin therapy (75mg-162mg/day) as a primary prevention strategy at increased CVD
risk (10 year risk>10%, Framingham)” was ranked the least important. One participant
wrote this as “controversial in primary care”. This comment is consistent with the recent
Australian guidelines in which aspirin is not recommended for the management of
cardiovascular risk. Although, aspirin was strongly suggested in 2009 Malaysian CPG and
currently the 2016 ADA standards of care, the 2015 Malaysian CPG recommends aspirin
for primary care only if patients are above 65 years old.(6, 16, 49) Based on this recent
high level evidence the research team felt it was important to add the words, patients >
65 years old to Aspirin therapy (75mg-162mg/day) as primary prevention to decrease
CVD risk (10 year risk>10%, Framingham).
The majority of participants indicated that the Framingham risk calculator should be used
to calculate CVD risk and educate patients as more important over other indicators. The
most likely explanation could be due to data by World Health Organization showing that
50%-80% of mortality cases among patients with diabetes were due to CVD.(260)
109
The Simpler™ tool incorporated the results of the Delphi study and the recent 2015
Malaysian and 2016 ADA Standards of medical care.(6, 16)
3.5.8 Strengths of Phase One
The strengths of Phase One were the participation of a team of multidisciplinary
professionals involved in diabetes care. Both in Malaysia and Australia, pharmacists,
endocrinologists, diabetes nurse educators, dietitians and primary health care physicians
(GPs) are part of diabetes teams. Diabetes guidelines from Malaysia, Australia, the UK
and the USA stress the need for a multidisciplinary team in order to achieve clinical and
health related QOL outcomes.(6, 7, 16, 17, 49, 51) Participants were chosen from the
community, hospital, and academia and health administration covering both public and
private sectors. The panel of experts were actively involved in the design of the Simpler™
tool in terms of the order of indicators, content and layout. Participants were
purposively selected from a range of health professionals as the intention was for the
Simpler™ tool to be used among healthcare practitioners from both countries and among
a wide range of healthcare professionals. It is hoped that if these healthcare
professionals are involved in the development of the Simpler™ tool, then there may be
increased use of this tool in their respective professions. This distinction can be seen in
several studies where tools developed by a wide range of professionals from different
countries have found to be effective for their purpose.(205, 207, 209, 212)
Most participants provided positive comments on the tool and were supportive during
the Simpler™ tool development phase. There were no dropouts during Rounds 2 and 3
which highlighted the second strength of this study.
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Thirdly, the Delphi process took only three months to complete. In addition, consensus
was achieved on 36 out of 38 indicators, which further suggests the importance of
preselecting indicators rather than asking the participants for suggestions. Having a
selection of indicators in the questionnaire meant that more indicators had a higher
chance of achieving consensus. Similar results were also achieved in studies that
preselected indicators before presenting them to the panel of experts, as indicated in
Table 3.14.
Table 3.14: Response rate from participants and number of indicators that achieved
consensus
Study Type of study Response rate from participants (%)
No. of indicators where consensus was achieved
Chang AM et al 2010 (202)
Validate a tool to measure competency standards for advance practice nursing role
93.8 37/42
Thomas SK et al 2013 (209)
Develop list of hospital prescribing indicators in order to standardize types of high risk errors to facilitate data collection
100 80/109
Parsons C et al 2014 ((205)
Categorize appropriate medications for patients with advance dementia
100 87/97
Spencer R et al 2014 (208)
Identify and update prescribing safety indicators for GP
100 23/56
Prot-Labarthe S et al 2014 (206)
Develop a screening tool to identify inappropriate prescribing and omissions for paediatrics
71.4 104/108
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3.5.9 Limitations of Phase One
Although both Malaysia and Australia had similar diabetes practice guidelines, the
guidelines did differ on aspirin therapy for cardiovascular risk prevention strategies.
However, experts from both countries managed to arrive at a consensus despite this
difference. The limitation of Simpler™ is that the validation method involved experts
from only two countries namely Australia and Malaysia which means validation of the
tool is needed in other countries. Nevertheless, due to similar practice guidelines in
some countries, it is envisaged that the validation would not be a lengthy process.
All indicators in Part 1 and Part 2 of the Simpler™ tool were provided to the Delphi
participants as done in previous research(179). This could have introduced bias in the
participants’ responses, as they were only required to give their opinions on pre-existing
indicators. There was no requirement for them to contribute an indicator which may or
may not have been important to be included in Simpler™. In addition, participants in the
Delphi method gave their opinion based on their existing knowledge and
experience.(217) Although, the indicators were from published RCTs, some still chose to
base their opinion on current practice trends which may not be the best approach.
Nevertheless, the Simpler™ questionnaire consisted of a combination of indicators
required to be included in the hand-out and indicators which required consensus from
the majority. Thus, not depending entirely on participants’ opinions.(261)
Delphi rounds required much of participants’ time and commitment. As the rounds,
would have been repeated until consensus is achieved, some participants may have felt
the need to conform to group’s consensus in order to shorten the process. Despite that,
the number of rounds to achieve consensus in studies mentioned in Table 3.1 were
similar to number of rounds in this research.
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3.5.10 The next stage
Diabetes is a complex disease and there are many factors involved in achieving
appropriate glycaemic control and to prevent diabetes related complications. This phase
of the research has construct validated these factors. Pharmacists can utilise the
Simpler™ tool to facilitate targeted, consistent care and structured interventions in
enhancing the quality of diabetes care. Ideally, the clinical benefit as well as health
related QOL outcomes of the Simpler™ tool need to be evaluated. Phase Two of this
research tested the tool in terms of feasibility, adaptability and reliability and further
refined the Simpler™ tool. In Phase Three of the research, a randomised controlled trial
were conducted to show the effectiveness of the tool in measuring evidence-based
recommendations in addition to clinical and QOL outcomes.
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This chapter describes and discusses Phase Two of the study which was conducted
between May and August 2015. This phase consisted of a pilot study evaluating the
feasibility and adaptability of the Simpler™ tool in pharmacy practice settings. The
contents of the Simpler™ tool were previously developed and validated in Phase One of
the study. Phase Two involved the development of the Simpler™ training package and
evaluation of pharmacists’ knowledge before and after the training, their views on the
training content and experiences and perceptions on using the tool in their daily practice.
The chapter begins with an introduction on literature reviews followed by an explanation
of Phase Two and the study design, participant recruitment from both Malaysia and
Australia, development of the Simpler™ training modules and format of the training
sessions. It then moves on to describe the interview guide, data collection and analysis.
4.1 Introduction
Increasingly, pharmacists in primary health care settings are expected to provide
medication management services (MMS) that include working with patients on non-
compliance issues, managing patients with multiple chronic disease conditions and
regularly educating patients to improve quality use of medications.(118) As part of
patient-centred care, emphasis is placed on effective use of medications through
identification of MRPs, interviewing patients to explore reasons for non-compliance and
documenting the care given to patients.(61) Patients with multiple comorbidities require
complex care and are often on many medications.
Diabetes management, for instance, require pharmacists to address patient-centred
issues that may prevent patients from achieving targeted therapeutic outcomes. These
issues may include cultural eating patterns, inability to self-manage blood sugar levels,
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unfavourable job conditions and emotional stress.(262, 263) Pharmacists who have
practised in traditional roles such as dispensing medications might lack the confidence,
skills and experience to address these patient-specific issues.(264, 265) Although
continuous professional education or development (CPE/CPD) may address the need to
increase pharmacists’ knowledge, there is lack of studies documenting its effectiveness
in improving pharmacists’ competence in medication management. Studies that do are
mostly subjective data based on participants’ perception of its effectiveness rather than
measured objective data.(266, 267)
There is evidence indicating that effective learning is enhanced by a cycle that includes
observation, application, reflection and experience sharing.(268) Learning through
experience also known as experiential learning is used in both the medical and nursing
professions for continuing education.(269)
4.1.1 Credentialed diabetes pharmacist
Accreditation programs for pharmacists wishing to specialise in diabetes care such as the
credentialed diabetes pharmacist incorporates experiential learning which involves
supervised practice hours in MMS and an evaluation post completion.
Training and credentialing pharmacists in diabetes management equips them with the
required knowledge to provide specialised diabetes services such as the provision of
MMS. MMS were first introduced in the United States of America (USA) which enabled
pharmacists to implement pharmaceutical care to solve medicine related issues and
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achieve therapeutic outcome goals.(62) Since then, MMS have been adopted and
practised in many countries.
4.1.1.1 Diabetes MMS in Malaysia
The process to become a credentialed MMS diabetes pharmacist in government funded
hospitals and primary healthcare clinics in Malaysia includes a requirement to spend 38
hours of supervised practice hours in a diabetes medication management clinic,
conducting inpatient ward rounds and clinical case assessments. The pharmacists are
then required to undertake a written assessment on diabetes management according to
local diabetes practice guidelines.(270)
4.1.1.2 Diabetes MMS in Australia
In comparison, MMS pharmacists from both public and private institutions wishing to be
credentialed with the Australian Diabetes Educators Association (ADEA) are required to
complete a post graduate certificate in diabetes education and a minimum of 1000 hours
spent in practice to educate patients on self-management. In addition to practising
pharmacists, other healthcare professionals such as nurses, medical practitioners,
podiatrists, physiotherapists and dietitians are eligible to apply. As well as meeting the
criteria of the national core competencies for credentialed diabetes educators, they are
also required to complete a six-month mentoring program.(168) In order to be a
credentialed diabetes educator, a candidate must have obtained a graduate certificate
in diabetes education and management which is provided by various universities in
Australia.
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4.1.2 Short term diabetes management training program
Pharmacists however are not required to be credentialed to conduct MMS and therefore
not all pharmacists undergo targeted diabetes management training to provide MMS to
patients. Nevertheless, pharmacists’ perceived lack of time was found to be a continued
barrier for pharmacists’ participation in short term training activities as reported in
several studies.(166, 266, 271)
Various short-term diabetes management training programs targeted towards
pharmacists have previously been developed and tested in the USA and in Australia. For
instance, in 2010, pharmacists in the USA obtained diabetes management accreditation
on completing 25 hours of a diabetes education program with the National Community
Pharmacists Association (NCPA).(272) In Australia, the Pharmacy Diabetes Care Program
(PDCP) under the DMAS pilot study was carried out under the Third and Fourth
Community Pharmacy Agreements, funded by the Australian Government Department
of Health and Ageing.(273) The PDCP was conducted between 2005 and 2010. It focused
on the ongoing management and review of T2DM patients to facilitate quality use of
medication. Pharmacists involved in the pilot had to complete a workshop of 14 hours
which incorporated diabetes management, motivational interviewing and goal
setting.(274, 275)
Both the training programs mentioned above focused more on patient education and
self-care aspects of diabetes management and less on the clinical aspects of the disease
such as evidence-based medication management. Thus, there was a lack of a diabetes
training program that emphasised on evidence-based best practice and the clinical skills,
which include patient case assessment, provision of monitoring plans and documenting
interventions.
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A 2010 study identified the need for training programs which integrate theory into
practice to boost pharmacists’ confidence in MMS.(264) Therefore, a short-term
diabetes management training program focused on clinical aspects of diabetes and
which incorporated application of theory into practice were taken into consideration
during the Simpler™ training modules design phase.
Australia and Malaysia were chosen as study sites based on their similarities. Firstly,
community pharmacists from Australia and primary health care pharmacists from
Malaysia provided diabetes MMS to ambulatory patients.(4, 10) Secondly, both
countries had similar diabetes management guidelines.(6, 7) In addition, the research
teams had strong connections in both countries which facilitated the recruitment
process. While both countries shared some similarities, they did differ on income per
capita. Malaysia is a developing country with much lower income per capita than
Australia.(276) Thus, the piloting of the tool in both countries provided a unique
opportunity to compare the tool’s applicability and adaptability in different countries.
4.2 Objectives
The aim of this phase of the research was to develop a clinical training program on
diabetes management incorporating the application of the Simpler™ tool. In addition,
this phase of the research explored pharmacists’ perceptions of the tool’s relevance and
usefulness in delivering quality diabetes care.
The specific objectives were to:
1. Describe the development and validation of the Simpler™ training modules,
2. Present the findings of the pre- and post-training questionnaire,
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3. Report pharmacists’ views on the Simpler™ training package and
recommendations for further improvement, and
4. Explore pharmacists’ perceptions on the utilisation of the Simpler™ tool as well
as suggestions to improve the tool.
4.3 Method
This section describes the development of the Simpler™ training package, participant
selection and recruitment, delivery and evaluation of the training content, development
of the interview guide and finally the data analysis process.
4.3.1 Ethics approval
This study received ethics approval from the Curtin University Human Research Ethics
Committee on 18 December 2014 (Approval number: RDHS-06-14). Ethics approval was
also obtained from the Malaysian Medical Research & Ethics Committee, Ministry of
Health on 15 May 2015 (Approval number: NMRR-15-339-24167 (IIR) (See Appendix
4.1&4.2). Throughout the study, the researcher respected all rights, cultures and beliefs
of participants. Participants signed a consent form and were assured that their identity
would remain confidential and extracts from their comments would be anonymous.
They were also given the option to withdraw at any time. Participants were reimbursed
for their time and effort. There were no ethical issues raised during this phase of the
research. Data from audio recorders were erased once they were transcribed verbatim.
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4.3.2 Study design
The development of the training package and the training sessions were conducted
between January and June 2015 followed by participant interviews between July and
August 2015. Prior to the interviews, participants had the opportunity to apply the tool
in practice for a four-week trial period.
Pharmacists from both countries were trained to use the tool for skill uniformity before
utilising the tool in practice. This phase of the study explored the views of pharmacists
from both countries on the tool usage in their practice setting and whether their views
were different. The sample of participants from both countries were conveniently
selected based on the following criteria:
1. Being a full time registered pharmacist
2. Involved in the provision of diabetes MMS;
3. Have not undergone formal diabetes training;
4. Willing and available to participate in the research.
A recent systematic review on 11 studies conducted from 2001 to 2012 concluded that
on-line learning or e-learning improved pharmacists’ knowledge immediately following
training.(277) Given that the same review showed e-learning to be equally as effective
as face-to-face learning provided that sufficient support is administered, a decision was
made to conduct e-learning (on-line, self-directed learning) in addition to face-to-face
training. Since the student researcher was in Australia at time of the study, face-to-face
training sessions were conducted on the Australian participants first, followed by e-
learning sessions for the Malaysian participants.
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The Simpler™ training content incorporated patient case studies to enhance
pharmacists’ knowledge. Simulation exercises using virtual patients, live actors or
patient case studies similar to patients in real practice settings have been used before to
train medical and nursing students.(269) Similar formats utilising case studies in
medication management training programs for pharmacy students have also been
reported.(278, 279) The examples used in the case studies were based on the student’s
experience conducting diabetes medication reviews and as a preceptor supervising
registered pharmacists to become credentialed diabetes pharmacists.
The Simpler™ training package also incorporated pre- and post-training questionnaires
which tested pharmacists’ knowledge, attitudes and practice before and after the
training. Several studies have used a similar process in assessing pharmacists’
knowledge, attitudes and practice through the completion of a questionnaire before and
after being given training on disease management.(280-284) Studies suggest that
statistically significant improvement in the scores before and after training demonstrates
the effectiveness of the training program.
To investigate the feasibility and adaptability of using the Simpler™ tool in practice,
participating pharmacists were given a four-week trial period on completion of the
training session to use the tool before an in-depth interview was conducted. To develop
an overall framework for the interview process, Kvale’s seven stages for conducting
interviews was utilised followed by the requirements of consolidated criteria for
reporting qualitative research guidelines (COREQ).(285) The seven stages are as
follows.(286):
1. Thematising: Determining the purpose of the interview
2. Designing: The design of the qualitative study took account of the contracted
knowledge
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3. Interviewing: Interview conducted in accordance with the interview guide
4. Transcribing: Verbal interview to be transcribed into written form for analysis
5. Analysing: Analysing interview using an appropriate method. In this case, the
framework method for qualitative data analysis was applied.(287, 288)
6. Verifying: to establish the reliability of the results in terms of consistency and
the validity which refers to what needs to be investigated
7. Reporting: Reveal the findings of the study
Taking into consideration the research aim and objectives, this phase of the study used
mixed methodology that consisted of qualitative and quantitative data collection.
Quantitative data were used to analyse the difference between pre- and post-training
responses while qualitative analysis was used to gain insight into pharmacists’ opinions,
views and perceptions of the Simpler™ tool.
Qualitative methodology was suggested by Strauss and Corbin to be the appropriate
choice when more in-depth research was required about a phenomenon or
experience.(289) The qualitative component consisted of interviews which allowed an
understanding of experiences through participants’ perspective and beliefs.(290, 291)
The ability of qualitative study to explore the abstract side of behaviour such as
frustration, achievement and difficulty was considered more helpful than capturing the
magnitude of usefulness using a Likert scale as suggested in previous literature.(292)
The following sections will describe the development of the Simpler™ training package
including the development of training objectives, the pre-and post-training
questionnaire and the training modules. This is followed by pharmacist criteria involved
in the recruitment process. The duration of training sessions and the steps involved are
further described. Following the training, pharmacist experience utilising the Simpler™
tool is explored through semi structured interviews. Data obtained from the pre- and
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post-training assessment were analysed quantitatively for differences in performance.
Recurring topics from the interview data were investigated using qualitative framework
method as suggested by Boyatzis.(287) Phase Two research outline is illustrated in
Figure 4.1.
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Figure 4.1: Phase 2 research workflow
Rec
ruit
men
t
Non-diabetes credentialed
pharmacists (n=12)
Pharmacist identify potential
patients for recruitment &
check patient eligibility
criteria
Simpler™ training and
ongoing support given to
pharmacists by research
student
Pharmacist-delivered
intervention using the
Simpler™ tool
Inte
rven
tio
n
Ph
arm
acis
ts
Eval
uat
ion
1.Semi structured interview
on Simpler™ training &
Simpler™ utilisation in
practice
1.Framework method
analysis to identify emerging
topics
Dat
a A
nal
ysis
2.Quantitative analysis on
pre-& post-training
assessment
2.Pre-& post-training
assessment
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4.3.3 Development of the Simpler™ training package
The objectives of the Simpler™ training were constructed using Bloom’s taxonomy
for knowledge-based goals, skills-based goals and affective goals.(293) On
completion, participants should have demonstrated an understanding of a
pharmacist’s role in providing diabetes care and how the Simpler™ tool facilitates the
provision of structured diabetes care. In practice, they should have been able to
apply the tool to identify reasons for therapeutic failure and solve the issues by
providing evidence-based suggestions using a systematic approach. The following
factors informed the design of the modules:
1. Relevance to practising pharmacists
2. Based on evidence-based practices, as per local diabetes practice
guidelines
3. Easily accessible via on-line modules
4. Comprised of clinical scenarios that simulate real practice to facilitate
knowledge application
5. Short, concise and incorporated a practice session
6. Included pre- and post-training assessments
The topics selected were based on another study on a pharmacists’ training program
that aimed to cover patient-centred care. That study demonstrated an improvement
in pharmacists’ skills and knowledge.(280) In addition, an overview of local diabetes
practice guidelines such as the Australian general practice management of type 2
diabetes (7) and the Malaysian diabetes clinical practice guideline (6) were
considered important to be included.
The training programme outline, pre- and post-training questions, and presentation
slides were peer-reviewed by three academics from the School of Pharmacy, Curtin
University. The accuracy, typographical, grammatical and formatting errors were
rectified before the pilot testing by two Malaysian and two Australian pharmacists
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who were experienced in the management of patients with diabetes. The
pharmacists provided feedback on the accuracy, content validity and
appropriateness of the training modules.
4.3.3.1 The Simpler™ training modules
The Simpler™ training package included four modules, Modules 1, 2, 3 and 4. The
content of each module was informed by the results of the Australian government
department of health and ageing pharmacists’ diabetes pilot program.(275) In the
final report, the pharmacists found the content useful, although they described the
training being more theoretical than practical and requested for more concise
information. This feedback was taken into consideration in designing the Phase Two
training package.
Participants had to complete module 1 first before starting on the next module in
ascending order. The learning objectives and goals are shown in Table 4.1. The
duration of the training session were two hours and twenty minutes to complete pre-
and post-training questionnaire. The two-hour time frame was chosen given
pharmacists time constraints for participation in training as mentioned in section
4.1.2.
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Table 4.1: Simpler™ modules contents and goals
Module no.
Module title Module content Module goals
1. Introduction 1. Describe the pharmacist’s role in management of type 2 Diabetes Mellitus
2. Explain the research objectives and significance
3. Outline the research plan and present results of the Phase 1 study
To provide an overview and understanding of pharmacists’ role in diabetes management.
2. Simpler™ tool validation
1. Outline and describe the seven indicators incorporated into Simpler™
2. Explain the benefits of Simpler™ using evidence-based information
To help pharmacists understand the Simpler™ tool development and evaluation process to increase confidence in its usage
3. Case study discussion
1. Outline the information gathering process
2. Practise effective intervention using the Simpler™ tool
To analyse the causes of therapeutic failure in case study example. To demonstrate and apply the Simpler™ tool to solve the issues. To justify each suggestion with evidence-based information using the Simpler™ tool
4. Writing intervention Notes
Writing case notes/*GuildCare using Simpler™
To compose patient notes using a systematic approach for writing
*GuildCare refers to the software used by Australian pharmacists to record and report patient information.
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Module 1 consisted of a 15-minute slide presentation. It provided an introduction to
the prevalence of diabetes in Australia and Malaysia and highlighted the urgency in
preventing complications among patients. It also described the methods used to
rank, prioritize and construct validate the content of the Simpler™ tool.
Module 2 consisted of a 30-minute slide presentation. It outlined the seven
indicators incorporated into the Simpler™ tool. It also explained the benefits of using
the tool as an evidence-based source as per local diabetes practice guidelines. It also
incorporated the medication management service (MMS) model.
Module 3 encompassed a practice session on a patient interview to obtain
medication management and compliance information. It also included a session on
using the Simpler™ tool to facilitate provision of pharmaceutical care.
Module 4 comprised of the legal aspects pertaining to writing in patients’ medical
notes. It also included a practice session on recording of observations, interventions
and writing a pharmacist care plan.
A more detailed Simpler™ training program outline consisting of modules 1 to 4 is at
Appendix 4.3. Appendix 4.4 presents the hand-out version of modules one to four
slide presentations. Figure 4.2 below summarises the flow of the training process.
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Figure 4.2: Flow chart summarises the flow of the Simpler™ tool training process
Although the contents of practice guidelines from Australia and Malaysia remained
generally the same, they did differ in terms of cholesterol, BGL and BMI goals of
treatment. Therefore, two versions of the training modules were designed. The
Australian version comprised of diabetes management goals according to Australian
general practice management of type 2 diabetes.(7) While the Malaysian modules
incorporated diabetes management goals and targets according Malaysian guidelines
for diabetes.(6) The Malaysian version of the modules were given a voice-over and
pre-recorded. Subsequently they were uploaded into a cloud service, the Google
drive. The link to the pre-recorded modules in Google drive were sent to the
participant’s email address. Participants from Malaysia could access the training
modules by clicking on this link. A visual presentation of the training modules is
shown in Figure 4.3.
Assessment
Post training questionnaire
Module 4
Develop medication care plan Document using Simpler™
Module 3
Apply Simpler™ to solve MRPs
Module 2
Case studies assessment
Module 1
Evidence-based best practice lecture
Assessment
Pre training questionnaire
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Figure 4.3: Overview of training modules uploaded into the cloud service.
4.3.3.2 Participant resources
Resources were provided to each pharmacist to facilitate the effective application of
the Simpler™ tool in practice. These included:
• A hand-out version of the slide presentations (Appendix 4.4)
• A page with relevant websites mentioned in the training modules
(Appendix 4.5)
• The Simpler™ tool hand-out (Appendix 4.6)
• Link to the video presentations of Modules 1-4 (only available to
Malaysian participants)
• The researcher’s (SA) telephone number. An Australian mobile number
was available for Australian participants and Malaysian pharmacists used
a mobile application called WhatsApp.
4.3.4 Recruitment of participants
The aim of qualitative analysis was to explore questions in detail until no new theories
emerged known as the saturation point.(294) Literature on sample size determinants
for qualitative study provided some guidance on selecting appropriate numbers of
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participants.(295) For qualitative research on lived experience of a participant, a
sample size between five and 25 is acceptable.(290, 296) Taking this factor into
consideration and pharmacists’ potential time constraints (297, 298), 13 pharmacists
were recruited for Phase Two, namely seven from Australia and six from Malaysia.
The target participants were primary health care pharmacists who provided MMS for
patients with diabetes and in full-time employment. As mentioned previously, in
Malaysia this is known as Medication Therapy Adherence Clinic (MTAC Diabetes) and
in Australia it is known as Diabetes MedsCheck. In addition, the participants chosen
were not credentialed diabetes pharmacists.
Participants were recruited through personal contacts of the researchers as well as
through snowball recruitment. Pharmacists in Australia worked at privately owned
community pharmacies while pharmacists from Malaysia worked in government
funded primary health care clinics. Six pharmacists from Johor, Malaysia and seven
from Perth, Australia expressed interest. An introductory letter was sent to these
pharmacists with details about the research (Appendix 4.7).
Participants who agreed were subsequently supplied with a participant information
sheet (Appendix 4.8) and consent form (Appendix 4.9) (via email to participants who
have given their email contact). Participants were given the opportunity to address
any questions. One participant from Australia who had initially expressed interest to
participate left the study, therefore the final number of participants were 12.
Once signed consent forms were received the training began. A link was given via
email to participants who were doing it on-line. All participants were allocated a
unique identification number. They were assigned the letter P. Participants from
Australia were numbered 1 to 6 and letter A was assigned. Participants from Malaysia
were also numbered 1 to 6 but instead letter M was assigned.
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4.3.5 Training session evaluations
The face-to-face training sessions for the six Australian participants took two hours
and were repeated to three groups of two pharmacists each to work around the
participants’ availabilities. Pharmacists were given 10 minutes to complete the pre-
training questions as well as 10 minutes at the end of the training session to answer
the post-training questions. Completed pre- and post-training questions were
collected at the end of the sessions.
The six Malaysian participants had to complete the pre-training questions before
being provided the link to the video presentations of Modules 1 to 4 which took
approximately two hours to complete. They were given a two-week deadline to
complete the modules. Upon completion, the pharmacists were requested to
complete the post-training questions.
4.3.5.1 Pre- and post-training questionnaire
The intention of the pre- and post-training questionnaire was to assess the
knowledge and skills of pharmacists before and after undergoing the training. The
questionnaire was developed and validated by three university academics and four
pharmacists with community and hospital backgrounds from Australia and Malaysia.
The questionnaire contained two sections; section A and section B as follows:
Section A: Five closed ended questions directed at participants’ training background
and practices at the time of study.
Section B: This section aimed to test participants’ knowledge on diabetes guidelines
and skills in making medication management interventions in patients with diabetes.
It included two open ended questions based on a patient case scenario. The
questions from the second section were repeated following the training session
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through the post-test. The pre- and post-training questionnaire is attached
(Appendix 4.10).
A marking scheme was developed (Appendix 4.11). Each point answered correctly
was awarded one mark. The marking scheme was validated by an independent
pharmacist. Feedback on inconsistency and answer variations led to the amendment
of the marking scheme and the revised version is at Appendix 4.12. Two markers
marked both the pre- and post-training questionnaires, providing quality control.
Final marks from each marker were analysed separately for significant improvement
between pre- and post-training. The findings are presented in the results section.
4.3.6 Semi-structured interviews
Semi structured interviews were conducted to obtain detailed information on the
participants’ experience in using the Simpler™ tool. Face-to-face interviews were
conducted with participants who were available to meet at an appropriate time and
venue (i.e. private room in the community pharmacy). Telephone interviews were
arranged for those who were not able to have face-to-face interviews mainly due to
geographical reasons and work commitments. All interviews were conducted to
ensure privacy and confidentiality. The main points covered in the interview were
presented to the interviewees prior to the interview. The interviewer followed the
interview guide, allowed room for probing questions but at the same time was able
to follow interesting points raised during the conversation not covered in the
interview guide but relevant to the aim of the study. At other times, the interviewer
had to rephrase the questions in another language due to English being the second
language for some interviewees. The interviewer ended the interview when all
questions were exhausted and no new information was obtained. Interviews were
recorded using an audio recorder to focus on the discussion. Audio recordings were
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saved with the same corresponding identification code allocated earlier to
participants. Recorded interviews were transcribed verbatim. Member of the
research team checked all transcriptions for accuracy against the audio recordings as
a quality check.
4.3.6.1 Interview guide
The interview guide was developed to obtain feedback on the effectiveness of the
training modules and the Simpler™ tool. Questions focused on the perceived
benefits, relevance and areas of improvement. Members of the research team
reviewed the content and amendments including changing some of the questions
from closed-ended to open-ended questions to obtain more information.
The aim of the interview questions was to serve as a guide during the interview
session. The key overarching questions were questions such as; “Please comment on
your experience in using the Simpler™ tool”; “How are the medication reviews with
patients with diabetes different now compared to when you were not using the
Simpler™ tool?” and “What recommendations would you make to enhance the
feasibility of the tool?”. Questions were divided into three sections (refer to
Appendix 4.13 for interview guide). Below is an overview of the interview guide:
1. Section A: Eight close ended demographic questions on pharmacist
practice experience, post-graduate qualifications, diabetes management
training and practical experience.
2. Section B: Three close ended questions on their experience in conducting
Diabetes MedsCheck or working as a MTAC diabetes pharmacist, existing
tools or checklists used as an aid in making pharmaceutical interventions
and reference to local diabetes practice guidelines.
3. Section C: Eight open ended questions with some sub-questions. Question
one intended to probe participants on the relevance, ease of use and
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practicality of the Simpler™ tool. Question two included question on the
number of times pharmacists used Simpler™ to provide diabetes care.
Questions three to seven talked about the positive aspect of Simpler™ and
requested suggestions for improvement to the training modules and the
tool. The final question number eight focussed on any additional
comments from participants.
4.3.7 Data analysis
Data analysis was conducted separately for the pre- and post-training questionnaires
and for the semi structured interview. The data were analysed using quantitative
methods for close ended questions and qualitative methods for open ended
questions. Descriptive data analysis was performed using SPSS 22.0.(233) To assess
if there was a significant difference between pre and post-training scores, the
Wilcoxon Signed Rank Test for non-parametric test was used. The Mann-Whitney U
test was used to detect practice differences between Australian and Malaysian
pharmacists. The non-parametric test was used as the sample size was too small and
did not meet the sample size requirement for parametric testing.
For the qualitative analysis, the analytical process followed the framework method
for thematic analysis.(287, 288) The task of transcribing the data was conducted by
the candidate in order to become immersed and acquainted with the data as
suggested by the qualitative framework method.(288) The open ended research
questions were used as a guide in looking for emerging patterns. The transcripts were
coded according to the interview questions which became the topics. Additional
topics apart from the interview questions emerged during the analysis. Participants’
raw data were highlighted in order to identify sentences or keywords which were
assigned a descriptive label called ‘codes’. The codes were subsequently sorted into
categories. The transcribed data were read multiple times for the candidate to gain
136
familiarisation. Different viewpoints under the same category were grouped as
subtopics. Nvivo 10 software (299) facilitated the categorizing and data organization.
The candidate scrutinised the data again for new subtopics. Research project
supervisors (HLH,VBS,LBGT) verified the analytical process before finalising the
analysis.
4.4 Results
The findings from the pre- and post-training questionnaires and interviews with the
12 pharmacists from Malaysia and Australia are presented in the following sections.
Section 4.4.1 represents the participants’ demographic and practice experience data.
The data was obtained from both section A of the pre-training questionnaire as well
as section A of the interview guide. The thematic analysis results from sections B and
C of the interview guide is represented in section 4.4.2.
4.4.1 Participant demographic and diabetes practice experience data
Participants’ demographic data is presented in Table 4.2 with details on their age,
country of practice, gender, working hours per week and practice information. As
stated previously the inclusion criteria included not being a credentialed diabetes
pharmacist and thus the participants did not previously undergo any credentialed
formal training on diabetes management. Statistical representation of selected
demographic information is shown in Table 4.3.
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4.4.1.1 Demographic data
There was equal representation of participants from Australia (n=6) and Malaysia
(n=6). The average age of participants were 30.3 years (range 25-48 years old) with
the majority (7/12) under the 25 to 27 years’ age range. The average working hours
per week were 40.5 hours. Most participants were female (11/12).
Table 4.2: Australian and Malaysian participant demographics and practice
information
ID Age Country Gender Average Working hours/week
Years of practice
P1M 30 Malaysia Female 38.5 2
P2A 27 Australia Female 38.0 4
P2M 25 Malaysia Female 38.5 2
P3A 27 Australia Female 41.5 2
P3M 26 Malaysia Female 38.5 2
P4A 27 Australia Female 45.0 3
P4M 37 Malaysia Female 38.5 7
P5A 30 Australia Male 42.0 6
P5M 35 Malaysia Female 38.5 8
P6A 48 Australia Female 45.0 27
P6M 26 Malaysia Female 38.5 2
P7A 25 Australia Female 35.0 3
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Table 4.3: Statistical representation of participant demographic and practice
information
Parameters Mean (SD) Median (IQR) Minimum Maximum
Age 30.3 (6.8) 27 (7.8) 25.0 48.0
Working hours/week 40.5 (2.9) 38.5(5.8) 38.0 45.0
Years practicing as pharmacist
5.7 (7.1) 2.6(5) 2.0 27.0
SD= standard deviation; IQR= interquartile range
4.4.1.2 Diabetes practice experience
Participants’ pharmacy work experience ranged from two years to 27 years with an
average of 5.7 years. The majority (66.7%; 8/12) had less than five years of pharmacy
practice experience. However, in terms of experience conducting Diabetes
MedsCheck services or MTAC Diabetes, the majority (75%; 9/12) of participants had
less than three years’ experience (see Figure 4.4)
Figure 4.4: Length of years conducting diabetes MedsCheck or MTAC Diabetes
0
1
2
3
4
5
6
0-1 years > 1 year < 3 years 3-5 years >5years
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4.4.2 Training session evaluations
Training background included postgraduate degrees or qualifications. One
participant was accredited with the Australian Association of Consultant Pharmacy to
conduct medication reviews. The remaining participants did not have any
postgraduate qualifications. Five participants from Malaysia and two from Australia
previously attended a one-day training course on conducting diabetes medication
management review.
4.4.2.1 Factors that motivated pharmacist to participate in research
Participants had to rank the reason for factors that impacted on their decision to
participate in the study according to six categories using a Likert Scale: 1 to 5 (1= most
motivating and 5= least motivating). The categories were as follows:
• Obtaining CPD points
• Financial reimbursements
• Interest in the subject
• It was recommended to me
• I want to improve patient outcomes
• Others
Figure 4.5 presents participants’ responses. During analysis of the data the Likert
scales were reversed to 1 being the least motivating and 5 being the most motivating
to allow for easier data interpretation. In the others category, one participant
mentioned “want to learn more about this subject” and another participant cited “to
improve my knowledge in MTAC Diabetes” as reasons that motivated them to join
the research.
The categories that most participants selected which fell in the upper quartile range
of the Likert scale (namely 4 and 5) were Interest in the subject (83.3%; 10/12) and
140
Improve patient’s outcomes (91.7%; 11/12). Of interest was that most participants
(58.3%; 7/12) ranked Financial reimbursements as a low motivator (lower quartile
range).
Figure 4.5: Breakdown of factors that motivated pharmacists to participate in the
research
4.4.2.2 Pre- and post-training scores
Participants’ knowledge was tested using the pre-training questions (before the
training programme) and the same questions were repeated after the training (post-
training). Two independent markers marked the answers. There was a significant
improvement in post-training scores (P=0.002). Before attending the training
session, the median test score for participants from 1st and 2nd markers were 6.0 (IqR
1.31). The full marks being 27 marks. After attending the training program, the
scores improved to 13.25/27, IqR 2.56. The difference in pre- and post-test scores
were as shown in Table 4.4.
0 20 40 60 80 100
Obtaining continuing…
Finanical reimbursements
Interest in Subject
It was recommended to me
I want to improve patient…
Other
Percentage of pharmacists
1=Lowest motivation level
2=Low motivation level
3=Average
4=High motivation level
5=Highest motivation level
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Table 4.4: Pre- and post-training scores of participants (n=12)
Median (IqR) Z stat ap value
Pre-test Post-test
Test score (1st marker) 6.5 (1.4) 14.3 (4.5) -3.063 *0.002
Test score (2nd marker) 5.3 (2.0) 11.3 (3.1) -3.065 *0.002
1st and 2nd marker 6.0 (1.31) 13.25 (2.56) -3.062 *0.002
IqR=interquartile range; Z-stat=number of standard deviations from the mean a p-value from Wilcoxon signed ranks test; b statistically significant
4.4.3 Semi-structured interviews
The following sections report the findings obtained from sections B and C of the
interview guide. The findings of participants’ diabetes practice experience (section B
of the interview guide) is presented first followed by a thematic analysis of section C
data. The thematic analysis followed the COREQ requirements.(285) The analysis
covered descriptive qualitative data followed by the thematic findings. Quotes from
participants’ data is included as supporting evidence for the key topics. As previously
explained, participants’ identity was replaced with codes to maintain anonymity.
All 12 pharmacists participated in the interview. Prior to being interviewed,
participants were given one month to familiarize themselves with the Simpler™ tool.
The average duration of the interview was 32 minutes. The length of the face-to-face
interviews ranged between 19 to 32 minutes (average= 26 mins) and the telephone
interviews ranged between 16 to 54 minutes (average= 36 mins). Face-to-face
interviews were conducted with four pharmacists and telephone interviews with the
remaining eight pharmacists.
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4.4.3.1 Number of patients seen by participants
A comparison of baseline data between Australian and Malaysian participants
revealed a difference between the average number of patients seen by participants
per month, with 4.3 patients on average (SD=2.3) in Australia and 19.8 (SD=13.3) in
Malaysia respectively. This difference was statistically different using the Mann-
Whitney U test, P=0.015 (P<0.05 is significant). Figure 4.6 provides a graphical
representation of this and other variables.
Figure 4.6: Pharmacy practice differences between Australian and Malaysian
pharmacists
4.4.3.2 Diabetes practice guidelines as source of reference
All participants referred to a documentation guideline for MMS protocol on the
management of patients with diabetes when asked about their reference sources.
Most Malaysian pharmacists used the standardized MTAC diabetes form to report
their interventions. Australian pharmacists on the other hand used a software
program (GuildCare®) to document relevant information. Interestingly, most
0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0
Australia
Malaysia
Australia
Malaysia
Australia
Malaysia
Australia
Malaysia
Age
(yea
rs)
Wo
rkin
gh
ou
rs/w
eek
Ave
rage
dia
be
tes
pat
ien
ts/
mo
nth
Ye
ars
of
pra
ctic
e
143
pharmacists (66.7%; 8/12) had never or only sometimes referred to the Australian or
Malaysian diabetes practice guidelines when providing diabetes MMS (Figure 4.7).
The guidelines referred to was the Malaysian ‘Clinical practice guidelines,
management of type 2 diabetes, 2015 and the Royal Australian College of General
Practitioners and Diabetes Australia, general practice management of type 2
diabetes, 2016-18.(6, 7)
Figure 4.7: Participant referral frequency to Australian or Malaysian diabetes
practice guideline
4.4.3.3 Perceived effectiveness of the Simpler™ tool
Participants’ perception on the effectiveness of Simpler™ in utilising the seven
diabetes factors to make evidence-based interventions was further explored
(interview guide question 1 of Section C). All 12 interviewees found the Simpler™
tool to be useful when conducting medication reviews with patients. Three specific
topics emerged around the perceived effectiveness of the tool namely:
1. The content was found to be relevant, structured, concise and easy to
understand,
2. The tool was found to be a point of reference, and
3. The tool was a reminder of the factors associated with diabetes management.
4
1 1 1
4
1
Never Always Whennecessary
often Sometimes Seldom
Nu
mb
er
of
par
tici
pan
ts
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4.4.3.4 Participants’ view on Simpler™ tool’s content
Participants used words such as ‘organized’, ‘sequential’, ‘straight to the point’, ‘my
accounting made relevant’, ‘compact’, ‘complete’ and ‘easiest tool’ to describe the
contents. Box 4.1 provides example quotes from participants.
4.4.3.5 The Simpler™ tool was found to be a point of reference
Participants from both Malaysia and Australia expressed their reliance on the
Simpler™ tool:
Yes, because all the indicators in Simpler™ tool are proven from local
guidelines and Australian guidelines so no one will dispute the contents.
(P2M)
Box 4.1: Key quotes from participants on the contents of the Simpler™ tool
Well I think that diabetes is so overwhelming, you just don’t know where to start, how to begin so having a structured approach is very beneficial. (P6A)
The existing diabetes guide for pharmacists are not as complete as yours. (P4M)
I just want talk about education, the part about the medication storage. This is a very important thing because one always do not think about medication storage. (P2M)
We think this is straight to the point. The existing guide for pharmacists, can be irrelevant and quite time consuming for us to go through. (P5A)
Simpler tool is a compact tool and one of the easiest tool. In one word, you can summarize everything. (P1M)
Patients deviate, I come back I might have missed the blood pressure component but with this one, when they deviate, I need to go through all these checklist, all these points, so it’s a good thing. (P3A)
145
So far, I rely heavily on Simpler™ tool because it has all the targets and
also it is based on Australian guidelines. (P2A)
The tool facilitated the recollection of the factors associated with diabetes
management. One pharmacist described the tool as a ‘simplification tool’. Whilst
some pharmacists portrayed it as a ‘supplementary tool’ others defined it as a
‘referral technique’.
4.4.3.6 Types of interventions made using the Simpler™ tool
The following findings were responses from Questions 2 and 3 under Section C of the
interview guide. On average Australian participants applied the Simpler™ tool on
three patients each (3±2) whereas the Malaysian participants applied it on 10
patients each (10±5.5) over the four-week period. Most of the participants (11/12)
used the Simpler™ tool to facilitate their intervention process. Participants reported
making interventions using one or more Simpler™ tool indicators as shown in the
data extracted during the interview. Table 4.5 presents the types of interventions
made, the corresponding intervention in the Simpler™ tool and the supporting
participants’ quotes. Participants showed more confidence in suggesting additional
medicines and recommending dose adjustment and managed to detect the reasons
patients did not achieve therapeutic outcomes.
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Table 4.5: Types of interventions made by pharmacists using the Simpler™ tool
Corresponding letter of Simpler™ tool
Type of Interventions Supporting quotes
S Statin/Cholesterol control Initiate statin So basically with [the] first patient, he was not on [a] statin, with Simpler™ that’s the first thing I actually spoke to him about, because he is at high risk (P7A)
I (Insulin/glycaemic control) Suggestion to initiate metformin
My first patient was not on metformin even though [it] is not contraindicated. (P6M)
I (Insulin/glycaemic control) Initiate insulin Patients with HbA1c constantly above 7% (53mmol/mol), I gave suggestions to start insulin. (P1M)
M (Medication management) Patient’s compliance Yes, it was simply compliance because he was not seeing that this medication is necessary for him and that includes his diabetes medication (P3A)
M (Medication Management) MRPs identified Because blood sugar is not controlled, [the] doctor increased [the] metformin dosage from 1gm to 2gm but the script is for just immediate-release metformin 1g, 2 tablets at night which is the wrong dose because immediate-release dosing should be 1 tablet twice daily (P5A) I managed to do a quick medication review and found that his lipid dose, fenofibrate actually, was too high for a patient with creatinine clearance of 45 and I suggested [to the] doctor to change it to 96mg daily rather than 145mg daily. (P5A)
L (Lifestyle management) I (Insulin/Glycaemic control)
Diet, foot care, BMI Hypoglycaemia management
... I did a lot was lifestyle, when we talked about lifestyle she had hypoglycaemia so we talked about hypoglycaemia. This other patient has her BMI as 29 so we talked about BMI. She is quite eager so we talked about plate model. (P2A) His diabetes levels weren’t well controlled and when we went through Simpler™, I realised his diet wasn’t very healthy. So I went through the diet and he also mentioned that he doesn’t check his feet regularly as well because with diabetes
147
Corresponding letter of Simpler™ tool
Type of Interventions Supporting quotes
you need to get your foot checked regularly so I advised him the importance of checking his foot regularly. (P4A)
R (CVD risk reduction strategies) Suggestion to initiate aspirin based on Framingham risk score
Based on that, the patient fit the criteria to start aspirin, therefore I advised the patient and recorded the intervention (P1M)
CVD= cardiovascular disease; BMI= body mass index; HbA1c= glycated haemoglobin; MRP= medication related problem
148
4.4.3.7 Comparison to previous practice
Responses from Question 4 under Section C of the interview guide indicated participants’
increased confidence levels and differences in the way they practised patient reviews
compared with those performed previously. One participant commented:
In my practice, I learnt something new because previously I did not write any
intervention, I mean I just counselled the patient based on their medication
but now I am comfortable to make an intervention. (P1M)
All participants agreed that the tool facilitated the writing of interventions in patients’
medical records. One participant reported that doctors were impressed with her
detailed patients’ notes.
Because I’m using Simpler™, I wrote clearly inside the patients’ book, the
doctor complimented that it was good and well written. They salute the
pharmacy, but before this I only used simple words and my notes were
incomplete. (P4M)
One participant felt that Simpler™ empowered pharmacists to extract relevant data from
patients:
I guess the differences would be we don’t just rely on existing computer
tools, we can also check blood sugar level whereas before this we don’t ask
for laboratory results, we counsel patients based on their medications and
dispense their medications. Now we try to contact the doctor and get the
laboratory results so that we can conduct a detailed medication review.
(P5A)
149
Two participants agreed that Simpler™ allowed them to conduct more thorough reviews
during consultations:
I go a bit thorough and ask more questions according to Simpler™ and find
out a little more and counsel and educate patients a little bit more. So,
usually when I’m doing my diabetes MedsCheck, I run through what’s on the
existing software program but then it’s not enough so Simpler™ pushes [me]
to do a bit more. (P7A)
We are providing a bit more information to patients rather than just doing
our normal MedsCheck. (P4A)
4.4.3.8 Positive aspects of the Simpler™ training sessions
The following findings were responses from Question 5 under Section C of the interview
guide. Pharmacists (10/12) opined that the training content was adequate and
structured. The length of training was appropriate.
I think it’s good actually, because you have provided us with the slide show
and the guidelines. It is relevant. (P5M)
Like all the study references you forwarded to us, all the evidence and all the
readings that you emailed to us, they were relevant. We could do a letter to
doctor and quote those studies or make a reference to those studies. (P3A)
While some participants (41.7%; 5/12) found face-to-face training more interactive,
58.3% (7/12) preferred the online training:
I think it really depends on personal preference though, because if it’s on-
line, I would not do it, I generally I prefer to see face-to-face and listen to
the person talk. (P4A)
150
The Simpler™ training session increased their knowledge on evidence-based diabetes
management and for some it served as a refresher:
Good. Because it’s still can remind me, I mean like a revision. The
Framingham risk score for example, I really forgot about that part. (P6M)
The on-line training session was clear and relevant:
The video presentation was clear and your information is so relevant and
you appropriately saying one thing clearly I think is good. (P1M)
Training sessions increased participants’ overall confidence in diabetes management.
One participant expressed that she was more confident to record interventions on
patient medical notes after the Simpler™ training session:
You know what’s good, the example you gave us in the Simpler™ training of
the little lecture that you sent to the doctor about the patients that is
helpful. But I haven’t sent anything to the doctor, but I still have the
confidence to send the doctor something like that. (P7A)
Facilitators for the training sessions were reported as Figure 4.8 shown below:
Figure 4.8: Training session facilitators
Modules easy to understand
Resources provided helpful
Length of training hours is adequate
On-line training is ideal
Face-to-face training is simple, easy and exciting
Confident after training
Refresher and upskill
151
4.4.3.9 Suggestions for improvements
The following findings were responses from Question 7 under Section C of the interview
guide. Participants were asked for recommendations to improve the training sessions
and the tool’s hand-out.
Improvements to training sessions
Two (of 12) participants believed the training content was too concise and
recommended more focus on detection of medicine related problems and lifestyle
issues. These suggestions and other recommendations for improvement with respect to
future training sessions were summarised in Figure 4.9. These suggestions were
incorporated into the training modules.
Figure 4.9: Recommendations to improve future training sessions
A template to record interventions
More information on:
• glucagon treatment
• diet
• medicine related problems
• hand-out to patients
• lifestyle
To retrieve patient's data first before making intervention
152
Simpler™ hand-out improvements
Three participants expressed a need to use visual prompts or larger fonts for headings in
the Simpler™ tool. One participant could not recall the 8MMMAS (188) or the plate
model for diet control (226) and therefore proposed their inclusion in the tool. As the
tool contained both Malaysian and Australian clinical outcome targets,
recommendations included to use either of the targets depending on the location the
pharmacists were practising. However not all participants agreed with this as some
preferred both targets considering different BMI recommendations for Asians compared
to Caucasians. Suggestions for improvements are summarised as Figure 4.10 below:
Figure 4.10: Participants’ suggestions for improvement to the Simpler™ tool
Sugg
est
ion
s to
imp
rove
Use visual prompts
Larger font for headings
Add adherence tool and plate figure
To incorporate either Malaysian or Australian therapeutic
targets
Use terms like Asian or Caucasion for BMI targets
153
4.4.3.10 Emerging qualitative analysis topics
There were several issues that emerged from the interviews when participants were
asked to describe their experiences on using the Simpler™ tool. These issues were not
part of the interview questions. These issues were grouped into topics; 1) implications
of application of the Simpler™ in practice, 2) facilitators and 3) barriers experienced by
the participants.
4.4.3.11 Implications of the Simpler™ tool in diabetes management
Although none of the issues below were specifically included in the interview questions,
five subtopics emerged during the analysis presented in Figure 4.11. These subtopics
were that the tool facilitated pharmacists’ role; it was specific for diabetes management;
it presents a competitive edge; it has wider usage than its original intention to facilitate
the provision of MMS; and finally, to target glycaemic improvement.
Figure 4.11: Five topics that emerged from the analysis
Facilitate pharmacists' role
Wider usage
Specific for diabetes
management
Target glycaemic improvement
Presents competitive edge
154
1. Facilitate pharmacists’ role
The perception that Simpler™ facilitated pharmacists’ role in diabetes management
was raised by two participants. The participants felt positive that the tool facilitates
their role as medication managers:
Really good thing and I think if a pharmacist can set themselves up to be a
specialist in diabetes management through using the Simpler™ tool
reporting back to the GP with 6 monthly progress. (P6A)
I guess when it comes to [the] community setting, we are not exposed to
detailed medication reviews but I think this is what we should be doing as a
community pharmacist, service based, for us to compete against retail
supermarket chains (P5A)
2. Tool targets diabetes management
Simpler™ was viewed as a tool specific for diabetes management in comparison to the
existing method such as Guildcare (Australia) software program used to document
pharmacist’s interventions. This is because the program was also used to document
interventions for other chronic diseases and not specifically for diabetes.
That one you have to print from the GuildCare program [software to support
provision of professional services] itself. Yes…You have to click, you just
register your patients and you just print it out. It doesn’t ask anything…all it
asks is, does this patient have T2DM? And then classifies as diabetes
MedsCheck so it doesn’t have what your tool has, specifically for patients
with diabetes. (P3A).
155
3. Simpler™ presents competitive edge
When asked if participants would encourage other pharmacists to use Simpler™, all
(n=11) except one (P6A) advocated for its use. Pharmacist P6A was not keen to
recommend Simpler™ to other pharmacists because she believed from a business point
of view, Simpler™ would give her pharmacy the advantage of delivering better diabetes
care than other pharmacies:
Well no because I want a competitive edge. I don’t want anybody else to
know about it. (P6A)
4. Potential application for wider usage
Some suggested to extend the use of Simpler™ for diabetes management during the
routine dispensing processes, and some during pharmacist internship or pharmacist pre-
registration:
We can also use it when we are doing dispensing. We can go through
patient’s profile whether they are taking statin medication. If they say no,
you can ask them how their cholesterol is. And they can always ask their
doctor for cholesterol test and we can do a clinical intervention. (P2A)
In all setting of course. I will especially recommend Simpler™ to hospital
pharmacist specifically intern pharmacists because it will help them so much
because they are new and they do not how to write good comments in
medical records. Since other health professionals read it, it’s very important
to write correctly. (P2M)
156
The fresh graduates, some of them have been practicing in the community
but not conducting diabetes MedsCheck. At least with Simpler™ and quick
training they know what to do. Based on Simpler™ they will be more
confident during consultation with the patient. (P5A)
5. Target glycaemic improvement
The fifth emerging topic was pharmacists’ aim of diabetes management became more
focused on clinical outcomes such as reduction in HbA1c.
Before this we only focussed on the education part, now the interesting part
is the aim to reduce HbA1c. (P4M)
4.4.3.12 Emerging topics: perceived facilitators and barriers
In addition to the above, participants also perceived the following as Simpler™ tool
facilitators, summarized in Figure 4.12. The Simpler™ tool provided structured and
organized method for pharmacists to follow during the patient medication review
process. The tool was found feasible in the practice setting as it reduced consultation
time, facilitated the documentation process while providing relevant information to
patients. Pharmacist were confident to use the tool as the contents were relevant and
have previously been validated in Phase One of research.
157
Figure 4.12: Facilitators of the Simpler™ tool
• provides counselling points
• useful content
• streamline issues to address
• organized
• thorough consultation
Structure interviews
• shorter consultation time
• facilitate recording
• easy to remember
• made intervention
• provide information to patients
• detected therapeutic problems
• more clinical
• detailed medication review
Relevant to practice
• confident
• able to focus during consultation
• focus on reducing HbA1c
• focus on appropriate treatment
Enhance skills
• relevant
• adequate
• hand-out very useful
• trust Simpler
• straightforward
Appropriate content
158
While Simpler™ was perceived as a facilitator to drive the delivery of evidence-based
care by most of the participants, six participants (6/12) faced challenges that hindered
them from using Simpler™ effectively. Three pharmacists reported that the tool was
time consuming but perceived the tool’s comprehensive medication review outweighed
the increased duration it took to complete the review process. In addition, due to
specific use, two pharmacists felt that training in diabetes management was required in
order to use the tool effectively. Two pharmacists expressed the difficulty in obtaining
laboratory data and thus were unable to conduct a detailed medication review. These
barriers and supporting quotes are summarized in Table 4.6.
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Table 4.6: Barriers and challenges in using Simpler
Barriers & Challenges Supporting quotes
Time consuming Initially when we first applied it, since we are not familiar, it was more time consuming. The whole session took me about an hour for the first patient. (P5A)
So it’s quite lengthy because we need to, as you know, and control the time because there are a lot of patients so we have to be fast. (P6M)
I need to go through all these checklists, all these points, so it’s a good thing, it’s longer but in a good way(P3A)
Unable to make intervention unless a HMR pharmacist
It’s fine but the only thing from Simpler™ tool I found that it would be much more applicable for an HMR pharmacist as opposed to a regular pharmacist in a pharmacy unless that pharmacist has been specifically trained in or even a diabetes educator actually. (P3A)
Need to be trained to use Simpler™
…. but we need to be trained first to use Simpler™ otherwise that we don’t have the basic knowledge to use it. (P5A)
Difficult to access laboratory results (Australia)
The only thing with diabetes MedsCheck and using the tool is that I can’t actually have access to their blood HbA1C results and I even tried to get it from the surgery. (P2A)
It was just at one point there was not enough laboratory test results in fact when I did medication review using Simpler™, I could only say” ‘Yes that there is statin’ but I do not know what the statin level was and what the cholesterol level was. (P3A)
4.4.4 Modifications to the Simpler™ tool
The findings from Phase Two led to modifications to the Simpler™ training modules and
the Simpler™ tool hand-out. Based on participants’ recommendations, additional
160
PowerPoint slides on the identification of medicine related problems were included in
Simpler™ training module 2. Information on glucagon administration was incorporated
into Simpler™ module 3. Some participants wanted more information on lifestyle, diet
and a hand-out for patients. In line with keeping the training modules to a two hour time
frame, relevant websites on patient’s education (300) and pharmaceutical care (61) were
signposted into the presentation slides (module 2) to enable participants to read and
download materials in their own time. These additional slides are presented as hand-
out versions in Appendix 4.14.
A proposal from participants to incorporate more visual prompts and less text were
acknowledged. As a result, the plate model (224) and questions from the 8-items
MMMAS(188) were included in the hand-out. Larger fonts were used to highlight the
primary word for each specific indicator. Since some of the clinical targets differed
between the Australian and Malaysian guidelines, incorporating both countries’ targets
in the same Simpler™ hand-out posed confusion to some participants. Therefore, two
separate hand-outs were constructed to account for the differences, as shown in Tables
4.7 and 4.8.
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Table 4.7: Revised Simpler™ tool hand-out (Malaysian version)
Simpler™ Pharmacist Diabetes Management Tool (Malaysia)
S=Statin • Statin initiation in patients with CVD • Achieve targets: LDL<2.6 mmol/L, TG<1.7 mmol/L. • Statin initiation in patients > 40 years old without CVD
I=Insulin/Glycaemic control
• Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
• Target of HbA1c ≤ 7% (53mmol/mol) if no other complications • Management of hypoglycaemia • Self-monitoring of blood glucose (4.4-7.0 mmol/L fasting);
(4.4-8.5 mmol/L-2h postprandial) • Aim a reduction of HbA1c by 1% if above target HbA1c • Initiate/continue metformin if not contraindicated
M=Medication • Assess medicine related problems • Review medication adherence using 8-items modified Morisky
medication adherence scale
P=Blood Pressure • BP target: ≤135/75 • ACEI/ARB initiation in patients with/without microalbuminuria
/proteinuria • Reduce sodium intake (<2400mg sodium/day; 6g/1 teaspoon/day) • One or more antihypertensive medicine to be taken at bedtime
L=Lifestyle
• Exercise: 30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
• Weight loss: Caucasian (BMI< 25 kg/m2 ), Asian (BMI ≤ 23 kg/m2) • Smoking cessation • Waist circumference: Caucasian (<94 cm in men,<80 cm in women,
Asian ( ≤90 cm in men,≤80cm in women) • Alcohol intake: ≤2 standard drinks (20 g) per day for men • Management of stress & diabetes related distress • Erectile dysfunction: recommend PDE-5 inhibitor as first line therapy
for male patients • Foot care • Diet advice using plate model • Annual eye assessment • Address sleep hygiene
E=Education • Knowledge & understanding of medicine • Medicine storage • Medication optimisation during fasting month for Muslims and other
religious groups
R=Cardiovascular Risk • Aspirin therapy as secondary prevention in those with diabetes with history of CVD
• Use of Framingham risk calculator to calculate CVD risk and educate patients
• Aspirin therapy (75mg-162mg/day) as primary prevention to decrease CVD risk (10 year risk>10%, Framingham) (patients >65 years old)
162
8-items Modified Morisky Medication Adherence Scale (page 2)
No. Questions Yes/No (Please circle)
1. Do you sometimes forget to take your pill? Y=0 N=1
2. People sometimes miss taking medications for reasons other than forgetting. Thinking over the past two weeks, were there any days when you did not take your medicine?
Y=0 N=1
3. Have you ever cut back or stopped taking your medication without telling your doctor because you felt worse when you took it?
Y=0 N=1
4. When you travel or leave home, do you sometimes forget to bring along your medications?
Y=0 N=1
5. Did you take your medicine yesterday? Y=1 N=0
6. When you feel like your disease is under control, do you sometimes stop taking your medicine?
Y=0 N=1
7. Taking medicine every day is a real inconvenience for some people. Do you ever get hassled about sticking to your treatment plan?
Y=0 N=1
8. How often do you have difficulty remembering to take all your medication?
Never/Rarely 1
Once in while
0.75
Sometimes 0.5
Usually 0.25
All the time 0
Score Low adherence=<6; Medium adherence=(6 to <8); High adherence=8
Total ___ /8
Plate Model
163
Table 4.8: Revised Simpler™ tool hand-out (Australian version)
Simpler™ Pharmacist Diabetes Management Tool (Australia)
S=Statin • Statin initiation in patients with CVD • Achieve targets: LDL<2.0 mmol/L, TG<2.0mmol/L. • Statin initiation in patients > 40 years old without CVD
I=Insulin/Glycaemic control
• Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
• Target of HbA1c ≤ 7% (53mmol/mol) if no other complications • Management of hypoglycaemia • Self-monitoring of blood glucose (6.0-8.0 mmol/L fasting); (8-10 mmol/L-
2h postprandial) • Aim a reduction of HbA1c by 1% if above target HbA1c • Initiate/continue metformin if not contraindicated
M=Medication • Assess medicine related problems • Review medication adherence using 8-items modified Morisky medication
adherence scale
P=Blood Pressure • BP target: ≤130/80 • ACEI/ARB initiation in patients with/without microalbuminuria
/proteinuria • Reduce sodium intake. Malaysian CPG: (<2400mg sodium/day; 6g/1
teaspoon/day) • One or more antihypertensive medicine to be taken at bedtime
L=Lifestyle • Exercise: 30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
• Weight loss: Caucasian (BMI< 25 kg/m2 ), Asian (BMI ≤ 23 kg/m2) • Smoking cessation • Waist circumference: Caucasian (<94 cm in men,<80 cm in women, Asian (
≤90 cm in men,≤80cm in women) • Alcohol intake: ≤2 standard drinks (20 g) per day for men • Management of stress & diabetes related distress • Erectile dysfunction: recommend PDE-5 inhibitor as first line therapy for
male patients • Foot care • Diet advice using plate model • Annual eye assessment • Address sleep hygiene
E=Education • Knowledge & understanding of medicine • Medicine storage • Medication optimisation during fasting month for Muslims and other
religious groups
R=Cardiovascular Risk
• Aspirin therapy as secondary prevention in those with diabetes with history of CVD
• Use of Framingham risk calculator to calculate CVD risk and educate patients
• Aspirin therapy (75mg-162mg/day) as primary prevention to decrease CVD risk (10 year risk>10%, Framingham): 2016 ADA Standards of medical care in diabetes
164
8-items Modified Morisky Medication Adherence Scale (page 2)
No. Questions Yes/No (Please circle)
1. Do you sometimes forget to take your pill? Y=0 N=1
2. People sometimes miss taking medications for reasons other than forgetting. Thinking over the past two weeks, were there any days when you did not take your medicine?
Y=0 N=1
3. Have you ever cut back or stopped taking your medication without telling your doctor because you felt worse when you took it?
Y=0 N=1
4. When you travel or leave home, do you sometimes forget to bring along your medications?
Y=0 N=1
5. Did you take your medicine yesterday? Y=1 N=0
6. When you feel like your disease is under control, do you sometimes stop taking your medicine?
Y=0 N=1
7. Taking medicine every day is a real inconvenience for some people. Do you ever get hassled about sticking to your treatment plan?
Y=0 N=1
8. How often do you have difficulty remembering to take all your medication?
Never/Rarely 1
Once in while
0.75
Sometimes 0.5
Usually 0.25
All the time 0
Score Low adherence=<6; Medium adherence= (6 to <8); High adherence=8
Total ___ /8
Plate Model
Grains
Fru
its
and
vege
tab
les
Protein
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4.5 Discussion
In the following section, the findings from this phase of the research will be discussed in
relevance to Phase Two objectives in six sections: 1) Participants’ demographic data and
pharmacy practice experience 2) Perceived effectiveness of the Simpler™ tool 3) Positive
aspects of the Simpler™ training sessions 4) Improvements made to the Simpler™
training modules and the tool based on participants’ recommendations. 5) Overall
implications of the tool and 6) Barriers and challenges limiting the tool’s usage. An
explanation of how the results from Phases One and Two were used to develop Phase
Three are also presented.
4.5.1 Participant demographic and diabetes practice experience
In terms of average number of patients seen in the pharmacy during the period of
research, Malaysian pharmacists had more patients than the Australian pharmacists.
This could be due to a difference in the number of diabetes (Type 1 and Type 2 DM)
population in each country. Malaysia’s 15.2% of adults with diabetes (20) compared to
Australia’s 5.1%.(301) Furthermore, Malaysia’s public health system provides more
affordable healthcare compared to private institutions which motivates patients to seek
treatment in government facilities.(302)
Most pharmacists reported unfamiliarity with practice guidelines as they relied on their
existing knowledge and standardized documentation to assist diabetes care delivery.
This could be due to lack of clinical support for community or primary care pharmacists
compared to hospital pharmacists. For instance, the Australian DMAS program
166
conducted in 2007 which was part of Australian government plan to prepare pharmacist
to deliver diabetes management service placed more emphasis on patient self-
management and education rather than the clinical aspects.(132) In Malaysia, lack of
support in terms of training programs other than for credentialed diabetes pharmacists
may be a potential cause.(270) A short-term diabetes training programs specifically on
clinical management according to practice guidelines such as Simpler™ may increase
pharmacists’ confidence and competency to deliver quality, evidence-based diabetes
care.
4.5.2 Perceived effectiveness of the Simpler™ tool
The Simpler™ tool was perceived a beneficial intervention tool to be used by
pharmacists. Potential benefits of guides to assist healthcare professionals to make
interventions are known. Among the reported benefits are improved quality of
interventions, clear recommendations offered to healthcare practitioners who are
unsure of how to progress, provide evidence-based suggestions and consistent
care.(303) Similar benefits were reported in studies using a defined approach to aid
decision making such as the intervention tool for prescribing antibiotics (178, 182),
asthma intervention tool for pharmacists (187), inappropriate medication use and
prescribing indicators in the elderly Australian population (180) and a dietary
intervention tool.(184) Participants’ evaluation of the effectiveness of Simpler™ was
similar to a hypothesis by Weed (177) who suggested two important features in order
for the tool to be effective: (1)the tool should enable information retrieval and
organization and (2) the tool should empower the user to use the information obtained
and own judgement to make an intervention.
167
It is interesting to note that participants have successfully adopted and adapted the
Simpler™ tool for making interventions in their respective countries. The Simpler™ tool
did not pose issues such as difference in culture and healthcare systems as reported in
one study conducted in multiple countries.(178) Although, the Australian guidelines
contained BMI targets specifically for Caucasian patients and the Malaysian guidelines
for Asian patients, some Australian participants opined the importance of having both
BMI targets in Simpler™ owing to the increasing number of Asian patients visiting their
pharmacy.
The present study raises the possibility that the Simpler™ tool can be used as a
‘communication tool’ between healthcare professionals and patients. This is because
the effectiveness of Simpler™ as an intervention tool is dependent on the data obtained
from patients’ clinical outcomes, compliance issues, lifestyle habits and knowledge. To
retrieve the data, pharmacists could utilise the tool to obtain responses from patients
and also counsel patients. This is also evident from the types of intervention pharmacist
made (section 4.4.3.6) using the Simpler™ tool. Pharmacists used the words; ‘streamline
issues to address’, provide ‘counselling points’, ‘provide information to patients’, and
‘detected therapeutic problems’ to describe the Simpler™ tool.
4.5.3 Positive aspects of training sessions
While some pharmacists preferred direct face-to-face training, more preferred the on-
line training. This finding corresponds to results of various studies which revealed
pharmacists’ preference for virtual training as it was ideal and relevant. This is because
online training does not require travelling time to a specific location which may be time
consuming. Furthermore, pharmacist daily work commitment will not be
168
interrupted.(281, 304-306) Similar to other studies (132, 278, 281), where pharmacists
perceived increased confidence after MMS training, the Simpler™ training modules
increased participant’s confidence to deliver evidence-based diabetes care in their
practice setting.
Participants’ interviews revealed the need for additional information on MRPs. This was
deemed unnecessary during the development of the training modules as the topic would
have been covered in pharmacists’ undergraduate degree programs in both
countries.(307, 308) In addition, the design of the training modules called for succinct
and concise information. However, despite these arguments, one study successfully
incorporated relevant clinical elements in their web-based training program for
pharmacists within a 60-minute time frame.(304) In contrast, another study required
pharmacists to interpret pathophysiology and pharmacotherapy of T2DM as
prerequisites prior to attending workshops as detailed discussion of these topics were
not conducted during training.(132) To address the shortfall in Simpler™ training
modules, additional slides were developed on pharmacotherapy workup. These slides
summarised the thought processes required to make pharmaceutical care intervention
according to Hepler and Strand.(61)
4.5.4 Overall implications of the Simpler™ tool
Participants’ recommendations for more visual aids and less words on the Simpler™ tool
was similar to a study on computer-based decision aids where users found the lengthy
recommendations posed a problem.(309) Concise recommendations were also found to
be more valuable in another study on decision aid tools.(310)
169
Simpler™ training managed to upskill the pharmacists as illustrated by the improvements
in the post-training questions and number of interventions made during the one-month
trial period. Most training programs which focused on pre- and post-training reported
similar improved pharmacist performance immediately post training.(278, 281, 311)
However, there is a lack of evidence of the longevity specifically in terms of
reinforcement of the information in these training programs. The Simpler™ tool on the
other hand consists of hand-out which remains with the pharmacists and therefore may
encourage continued use.
The five topics that emerged from perceived effectiveness of the Simpler™ tool were
associated with the Simpler™ tool’s targeted use in diabetes management. Participants
commented that the use of the Simpler™ tool could potentially be extended to
pharmacists during routine dispensing activities and as a training tool for pre-registration
or intern pharmacists. The tool motivated the pharmacists to facilitate improvements in
glycaemic control. Lack of existing intervention tools, specifically for the management
of patients, (14) may explain the reason why pharmacist found the tool helpful in their
daily practice settings.
In addition, participants with no prior training in diabetes management and limited
clinical experience could effectively make clinical interventions through application of
the tool. These findings provide some support for the conceptual premise that
pharmacists with limited clinical experience could effectively utilise the Simpler™ tool to
facilitate diabetes medication reviews.
170
The Simpler™ tool was found to be feasible by community pharmacists in Australia and
primary health care pharmacists in Malaysia as both countries had similar diabetes
guidelines (6, 7) and similar diabetes MMS.(10, 157) This raises the possibility that the
tool could be adapted to other countries with similar diabetes guidelines to Australia and
Malaysia such as the UK, the USA and European countries and who offer diabetes MMS.
The Simpler™ tool was found to facilitate recordings of interventions. This was important
as the intention of the tool is to promote quality, evidence-based interventions and
communication between pharmacists and prescribers through patients’ medical records
(PMR). Participants found the training module on recording interventions in PMR
helpful. The recording of interventions on patients’ notes are usually done by a clinical
pharmacists in the hospital setting but this is not traditionally practised by community or
primary healthcare pharmacists.(61) Despite this, participants who completed the
training expressed their willingness and were confident to record their clinical
interventions.
4.5.5 Barriers and challenges using the Simpler™ tool
The Simpler™ tool was deemed easy to use as participants were assumed to have some
knowledge of clinical practice guidelines and pharmacotherapy skills. However,
participants highlighted the need to be trained prior to using the tool. This finding was
similar to a study exploring general practitioners view on a web-based intervention tool
which postulated similar need as they were unfamiliar with recent medical
developments.(178)
171
One of the barriers faced by some pharmacists were access to PMRs. Two of the six
Australian pharmacists found access to patient’s medical data challenging. This could be
due to differences in practice settings in Australia and Malaysia as pharmacists in
Australian community settings were required to be proactive in acquiring laboratory
results from doctors’ practices. This issue could be the reason why one pharmacist
commented on the need for a Home Medicines Review (HMR) accredited pharmacist to
conduct interventions as patient data are more accessible to HMR pharmacists.(312)
Information from PMRs expedites pharmacists’ assessment of pharmacotherapy issues
and enable them to make quality interventions.(171) Pharmacists not able to access
patients’ laboratory results from PMRs were unable to make clinical interventions
despite applying the Simpler™ tool. This finding further suggests that the Simpler™ tool
is a clinical diabetes intervention tool and access to PMRs, including laboratory data, is
essential to make meaningful recommendations.
4.5.6 Limitations and suggestions for future work
Most pharmacists considered Simpler™ a highly acceptable tool to be used in diabetes
management. However, the risk of their views being biased towards a more positive
response during the interview session is acknowledged as shown in some studies.(277)
In addition, evaluation of the clinical outcomes in patients is needed to ascertain
pharmacist application of knowledge and skill acquired through training. The small
sample size from one state in Malaysia and Australia may not reflect the views of
pharmacists as a whole. As there was no direct observation, therefore participant’s
practice experience could not be validated quantitatively. However, the content of the
interviews revealed rich data which revealed topics and subtopics.
172
Majority of the participants in Phase Two comprised of the female gender. This was
because participation in this research were voluntary and based on participants’
availability. In addition, the unequal gender representation could also be due to the
increasing number of young female pharmacists in both countries. The 2017 data from
Pharmacy Board of Australia showed more female (62%) pharmacists than male
(38%).(313) A 2015 report on women pursuing university degrees in Asia, found there
were more female than male pharmacy undergraduates in Malaysia.(314) Nevertheless,
this research aimed to compare pharmacists’ views from both countries on the feasibility
of the tool in practice. The intent of this research was not, however, to explore the views
between the different genders. Therefore, equal representation of the genders was
decided not a prerequisite for this research.
Although the Simpler™ tool provides guidance on diabetes targets in order to achieve
therapeutic outcomes, it does not incorporate communication techniques such as
motivational interviewing.(315) Increasingly, motivational interviewing has been
suggested to increase patients’ compliance to lifestyle issues in diabetes.(316) As the
Simpler™ tool presents itself as a communication tool, it further reveals the need to
include a section on motivational interviewing in the Simpler™ training modules. In
addition, although the participants demonstrated improved knowledge and skills
assessed as pre- and post-training results, pharmacists’ effort in continuous education
to update expanding new evidence in diabetes remains to be seen. Future studies on
long-term impact of Simpler™ tool would provide evidence of its effectiveness.
173
4.6 Conclusion
This phase of the research resulted in the development of the Simpler™ training modules
and both the training modules and the hand-out were refined based on proposals from
participants in this research. This phase explored pharmacists’ experience in application
of the Simpler™ tool in the community (Australia) and primary healthcare setting
(Malaysia). The Simpler™ training program and tool is a useful approach to upskill
pharmacist and improve their confidence in delivering diabetes care. Pharmacists who
have limited clinical experience compared to their counterparts in the hospital setting
viewed the tool as relevant and beneficial in facilitating structured, evidence-based
interventions in practice.
Chapter 5
Impact of the Simpler™ Multifactorial
Diabetes Intervention on Type 2 Diabetes
Patients in Johor, Malaysia: A Randomised
Controlled Trial
175
5.1 Introduction
Pharmacists’ contributions to improving glycaemic control and other clinical outcomes
of patients with T2DM through provision of medication management services (MMS) are
widely documented.(13, 14, 116) As a result, pharmacists are increasingly recognised
for their role in T2DM management as important members of the healthcare team.
However, the uptake of MMS provision in community practice remain low as was shown
in a qualitative study.(317) One potential reason may be the lack of a specific
standardised approaches for pharmacists to adopt, especially among pharmacists with
limited clinical experience. Similar views were expressed in the findings from a recent
review which highlighted the need for pharmacists to follow a structured approach in
the management of T2DM patients.(13)
Most studies (RCTs, pre-and post-intervention, and retrospective) have reported
interventions on one or more of the seven diabetes management factors such as lifestyle
management, patient education, medication adherence, glycaemia, blood pressure,
cholesterol and CVD risk management. However, studies lack in utilising all seven
essential diabetes factors required to be addressed, mentioned previously in Chapter 2.
This phase (Phase Three) of the research trialled the impact of the Simpler™ intervention
tool on patients’ clinical and QOL outcomes. The Simpler™ tool was designed to address
all the seven factors required to be monitored in diabetes management. Phase Three of
the research was conducted in Malaysia.
176
5.1.1 Malaysian healthcare system
Malaysia is in Southeast Asia and comprises of 13 states and three federal territories.
Since it is in the equatorial region, Malaysia experiences tropical rainforest climate all
year. Malaysia’s population was estimated at 31.7 million people in 2016. The
Malaysians are of diverse multicultural ethnic backgrounds namely the indigenous
Melayu (68.6%), Chinese (23.4%) and Indian (7%) populations.(318) The national
language of Malaysia is Bahasa Malaysia although English is widely spoken. Malaysia has
experienced rapid urbanization and is the second most urbanized country in South East
Asia after Singapore, with 70% of the population living in urban areas.(319)
The Malaysian healthcare system comprises of a dual tiered system which consists of
government funded public services and privately funded services, referred to as private
healthcare The public funded institutions consist of primary, secondary and tertiary
care.(319) The primary health care clinics consist of Klinik Kesihatan (KK), Klinik Desa,
Klinik 1 Malaysia and mobile health clinics. KK provides comprehensive medical care
while Klinik Desa focuses on maternal and child health. Klinik 1 Malaysia are situated in
highly populated urban and semi-urban areas while mobile health clinic services are
provided in remote and rural areas. The private health care system focuses on provision
of health services in urban locations through general practitioner clinics and private
hospitals in addition to diagnostic laboratory and ambulance services.(319)
Whilst the primary care acts to treat and promote prevention of complications, patients
requiring advanced care are referred to secondary care and those requiring specialised
services are referred to tertiary care.(319) Malaysian citizens only pay a small fee for
treatment in the public institutions in comparison to private healthcare.(320) The
affordable care provided in the public sector meant more patients prefer public to
177
private care services. This has contributed to longer waiting times to receive
treatment.(321, 322) Specifically to pharmacy, public institutions provide a variety of
pharmacy services for ambulatory patients such as medication management services
(MMS) for chronic disease such as diabetes, methadone replacement therapy, home
medication reviews (HMR) and smoking cessation.(323)
In privately owned pharmacies, most patients visit community pharmacists for over the
counter medications, general health items, health screening, smoking cessation and for
medication information services.(324) In contrast to public pharmacists, community
pharmacists in Malaysia offer limited professional services. Unlike Australia (273) or the
UK (155), community pharmacists in Malaysia do not receive government funding for
extended pharmacy services such as MMS or HMR. Despite this, participants in a recent
qualitative study on community services in Malaysia did not recognize lack of funding as
an issue in providing those services. Instead, lack of collaboration among healthcare
professionals and regulatory constraints were cited as barriers.(325)
178
5.1.2 Determinants of glycaemia improvement
The overall prevalence of diabetes mellitus (DM) (known and undiagnosed) among adults
of 18 years and above in Malaysia was 17.5% according to the 2015 National Health and
Morbidity Survey.(21) Women had higher prevalence (18.3%) than men at 16.7% while
urban areas had more patients with DM (17.7%, 95%CI: 16.7, 18.8) compared to rural
locations at 16.7% (95% CI: 15.4, 18.1). Among the 13 states in Malaysia, Johor had the
third highest diabetes prevalence at 19.8% (95%CI: 16.8,23.3).(21)
A literature search to June 2017 revealed a total of eight published pharmacists-led
diabetes intervention studies conducted at primary healthcare centres and outpatient
hospitals in Malaysia, listed in Table 5.1. However, diabetes intervention studies
conducted in primary healthcare centres such as KKs were scarce. Most studies (6/8,
75%) were conducted in hospitals while only two (2/8, 25%) were conducted in KKs. In
addition, there were no documented RCT studies performed at multiple KK sites.
While the impact of pharmacist led diabetes intervention studies is widely documented,
specific improvement in glycated haemoglobin (HbA1c) has varied in Malaysian and
international RCT studies.(13, 14) HbA1c level is selected as the relevant clinical marker
in most diabetes studies as HbA1c 1% reduction is associated with a lower risk of
complications as shown in the UKPDS study.(326) A review of previous diabetes
intervention studies revealed several determinants were associated with HbA1c
reductions.(13) Those are: 1) study setting (community or clinical); 2) baseline HbA1c
levels; and 3) patients’ age.
179
Table 5.1: Diabetes intervention studies conducted by pharmacists in Malaysia
Authors, year
Design and setting
Arm size, mean age, mean baseline %HbA1c, %ethnicity, %gender
Number of patients’ visits to pharmacists
Types of Intervention, Methods
Pharmacist experience
Results Effect size
1.
Ayadurai,S et al, 2013(129)
Hospital, Johor, outpatient, Retrospective, cohort study
n=50, mean age:53.9; baseline HbA1c:11.72% (104.6mmol/mol); Ethnicity: Melayu:54%, Chinese:6%, Indian:40%; Gender: male:34%; female:68%
2-8 visits over 2 years
Medication adherence, drug related problem solutions, medication counselling, diabetes education and blood glucose monitoring
Credentialed diabetes pharmacist
HbA1c: Reduction from 11.72% (104.6mmol/mol) to 10.39% (90.1mmol/mol) =-1.33%; medication adherence and no. of hypoglycaemia events.
Cohen’s d=0.54 Hedges’g= 0.54
2. Butt M et al, 2016(158)
RCT, Outpatient teaching hospital, Kuala Lumpur
PC: n=33, mean age:57.4; baseline HbA1c: 9.66% (82.1mmol/mol), Ethnicity: Melayu:54.5%, Chinese:21.2%, Indian:24.2%; Gender: Male:39.45, Female:60.6% UC: n=33; mean age:57.1; baseline HbA1c:9.6% (81.4mmol/mol); Ethnicity: Melayu:60.6%, Chinese:24.2%, Indian:15.2%;
3 visits at 0, 3 and 6 months over 6 months
Patient Education by Pharmacist Programme (PEPP) on lifestyle, medication adherence and self-monitoring
Not reported
HbA1c PC:Reductioin from 9.66% (82.1mmol/mol) to 8.47% (69.1mmol/mol)=-1.19% UC: Reduction from 9.64% (81.9mmol/mol) to 9.26% (77.7mmol/mol) =-0.38%
Cohen’s d = 0.49 Hedges’ g = 0.49
180
Authors, year
Design and setting
Arm size, mean age, mean baseline %HbA1c, %ethnicity, %gender
Number of patients’ visits to pharmacists
Types of Intervention, Methods
Pharmacist experience
Results Effect size
Gender: male:42.4%, female:57.6%
BMI (29.34 to 28.92), 8-item MMMAS (5.83 to 6.77)
3. Chow EP et al, 2016(86)
RCT, KK, Pulau Pinang, Malaysia
PC: n=50; mean age:60.3; baseline HbA1c=8.92% (74mmol/mol); Ethnicity: Melayu:22%; Chinese:56%; Indian:20%, Gender: male:38%, female:62%; UC: n=69, mean age:60.3; baseline HbA1c:9.23% (77.4mmol/mol); Ethnicity: Melayu:49.28%; Chinese:33.33%; Indian:17.39%; Gender: male:36.23%, female:63.77%
2 visits over 2 months
Home based educational intervention, not specified
Not specified
PC: Reduction from HbA1c: 8.92% (74mmol/mol) to 8.19% (66mmol/mol)= -0.73% UC: No changes in HbA1c
Cohen’s d = 0.57 Hedges’ g= 0.56
4. Chung WW et al, 2014(159)
RCT, Outpatient Teaching hospital, Kuala Lumpur
PC: n=120; mean age: 59.7; baseline HbA1c=9.6% (81.4mmol/mol); Ethnicity: Melayu:50.8%, Chinese:21.7%, Indian:26.7%, Gender: male:41.7%, female:58.3% UC: n=120; mean age:58.5; baseline HbA1c:9.5% (80.3mmol/mol);
12 visits over 12 months
Medication review, resolve drug related problem, patient education and medication adherence, monthly follow-up telephone calls, pill box and blood glucose
Experienced pharmacists but details not reported
Improvement in medication adherence; FBG; PC: Reduction from HbA1c: 9.6% (81.4mmol/mol) to 8.2% (66.1mmol/mol)=-1.4%, UC: Reduction from HbA1c: 9.5%
Cohen’s d=0.70 Hedges’ g = 0.70
181
Authors, year
Design and setting
Arm size, mean age, mean baseline %HbA1c, %ethnicity, %gender
Number of patients’ visits to pharmacists
Types of Intervention, Methods
Pharmacist experience
Results Effect size
Ethnicity: Melayu:38.8%, Chinese:19%, Indian:38.8%; Gender: male:46.3%, female:53.7%
meter to record self-monitoring of blood glucose
(80.3mmol/mol) to 9.3% (78.1mmol/mol)=-0.2%
5. Haron N et al, 2015(160)
Multicentre retrospective, 14 KK, Kuala Lumpur and Putrajaya
n=56; mean age: 54.8; baseline HbA1c: 10.7%; Ethnicity: Melayu:57.14%; Chinese:21.43%; Indian:21.43%; Gender: male:44.64%, female 55.36%
4 visits over 15 months
Dosage adjustment, changes of medications
Credentialed diabetes pharmacist
Reduction of HbA1c: 10.7% (93.4mmol/mol) to 9.7% (82.5mmol/mol)=-1%, significant improvement in medication understanding and adherence level
Cohen’s d = 0.61 Hedges’g = 0.61
6. Lim PC et al, 2016(161)
RCT, outpatient, Hospital Pulau Pinang
PC: n=39; mean age:57; baseline HbA1c:10.11% (87.0); Ethnicity: Melayu:28.2%; Chinese:46.2%, Indian:25.6%; Gender: male: 46.2%, female: 53.8%; UC: n=37; mean age:55.6; baseline HbA1c:9.71% (82.6mmol/mol); Ethnicity: Melayu:32.4%,
8 visits in 12 months
Medication reviews, adding and adjusting insulin doses within 4 units each time and laboratory tests ordered, education and lifestyle advice provided
Credentialed MTAC diabetes pharmacist
PC: Reduction of HbA1c: 10.11% (87mmol/mol) to 9.21% (77.2mmol/mol) =-0.9%, UC: HbA1c: 9.71% (82.6mmol/mol) to 9.63% (81.7mmol/mol) =-0.08%,
Cohen’s d=1.50 Hedges’ g = 1.50
182
Authors, year
Design and setting
Arm size, mean age, mean baseline %HbA1c, %ethnicity, %gender
Number of patients’ visits to pharmacists
Types of Intervention, Methods
Pharmacist experience
Results Effect size
Chinese:35.2%, Indian:32.4%; Gender: male:45.9%, female:54.1%
Improvement in FBG, TC and LDL
7. Lim PC et al, 2010(327)
Retrospective, outpatient, Hospital Pulau Pinang
n=43; mean age:47.9; baseline HbA1c:10.82% (94.8mol/mol); Ethnicity: Melayu:46.5%; Chinese:44.2%; Indian:9.3%; Gender: male:46.5%, female: 53.5%
8 visits in 12 months
Dosage adjustment, addition of OHA, insulin, statin and aspirin, medication adherence and education
Credentialed diabetes pharmacists
Reduction from HbA1c:10.82% (94.8mmol/mol) to9.09% (75.8mmol/mol) =-1.73%, FBG, LDL and improvement in medication adherence
Cohen’s d = 6.24 Hedges’ g = 6.24
8. Navin KL et al, 2011(128)
RCT, outpatient, Hospital, Kuala Lumpur
PC: n= 42; mean age: not reported; baseline HbA1c: 10.6% (92.4mmol/mol); Ethnicity: not reported; Gender: not reported UC: n= 43; mean age: not reported, baseline HbA1c:10.7% (93.4mmol/mol); Ethnicity: not reported; Gender: not reported
9 visits in 12 months
Medication adherence, drug related problem solutions, medication counselling, diabetes education and blood glucose and weight monitoring
Credentialed diabetes pharmacists
PC: Reduction from HbA1c: 10.6% (92.4mmol/mol) to 8.9% (73.8mmol/mol) =-1.7%, UC: Reduction from HbA1c: 10.7% (93.4mmol/mol) to 10.1% (86.9mmol/mol)=-0.6%; improved medication
Calculation could not be performed as standard deviation was not reported
183
Authors, year
Design and setting
Arm size, mean age, mean baseline %HbA1c, %ethnicity, %gender
Number of patients’ visits to pharmacists
Types of Intervention, Methods
Pharmacist experience
Results Effect size
adherence score (4.23 to 7.84)
Melayu refers to ethnic Malay whose origin dates to Indian, Chinese, Cambodian and Indonesian heritage(328) and indigenous population in Malaysia; Indian refers to population from India, Sri Lanka, Pakistan and Bangladesh who migrated to Malaysia in the 3rd and 19th century(5); Chinese refers to population from China who migrated to Malaysia in the 3rd and 19th Century(5). FBG=fasting blood glucose; HbA1c= haemoglobin A1c; LDL= low density lipoprotein; MTAC= medication therapy adherence clinic; PC= pharmaceutical care; RCT= randomised controlled trial; TC=total cholesterol; UC=usual care;
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The studies conducted in hospital settings showed larger mean improvements for
HbA1c in comparison to the community or primary healthcare settings. Studies
conducted in hospital settings showed mean differences of -0.9% to -1.73% after
intervention while studies conducted in primary settings ranged from -0.73% to -1%.
The effect size or the size of HbA1c changes based on sample size of the study
between intervention and control arms ranged from 0.57-0.61 in primary settings
and 0.49-1.5 in hospital outpatient settings. The increased HbA1c changes reported
in hospital settings could be due to interventions by experienced clinical pharmacists
whereas pharmacists in community settings may have less expertise in the clinical
aspects of T2DM management. This view was supported by findings from a study
which found pharmacists’ educational background were facilitators of MMS provision
and suggested enhanced practice experience and the need for clinical knowledge to
build pharmacists’ confidence.(264) Furthermore, the better outcomes among
hospital outpatients may be due to enhanced self-care support provided by
healthcare professionals (HCP). In comparison, primary care patients often lack the
support due to constraints in the provision of care. The findings from a qualitative
study conducted in Malaysia among T2DM and HCP in primary and secondary care
supports this view.(329)
5.1.3 Diabetes management among Muslim patients
Malaysia is a secular country, as such while Muslims make up the majority of the
population (61.3%), other religions such as Buddhism (19.8%), Christianity (9.2%) and
Hinduism (6.3%) are also freely practised.(330) Of specific relevance is the Muslim
population where individualised care is necessary among patients with diabetesdue
to religious diet issues.(331)
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During the Muslim month of Ramadan, Muslims worldwide, including those from
Malaysia, practise fasting whereby they refrain from oral or intravenous substances
from sunrise to sunset for a period of 30 days. Although Muslim patients are not
required to fast according to their religion(6), some patients do participate in the
practice of fasting. Thus, it becomes increasingly important for healthcare
professionals to be educated in diabetes management, particularly the need for
medication dose adjustments to avoid risks of hypoglycaemia, hyperglycaemia and
dehydration.(332)
Malaysian diabetes practice guidelines outline several recommendations during
fasting such as medication dose adjustment and timing, reduced physical activity,
adequate fluid intake and breaking the fast when hypoglycaemia is experienced.(6)
Several studies on fasting practice among Muslim patients documented significant
improvements in HbA1c and fasting blood glucose after a three month education
intervention which included medication dosage and timing adjustments.(332, 333)
However diabetes intervention studies led by pharmacists in Malaysia have rarely
reported intervention strategies adopted during the Ramadan fasting period.
5.1.4 The state of Johor, Malaysia
Johor is situated at the south of the peninsular of Malaysia with a population of 3.7
million. The major ethnic communities in Johor comprise of Melayu (2 million,
54.1%), Chinese (1.1 million, 29.7%) and Indians (0.23 million, 6.2%) and there are
more men (1.9 million, 51.3%)) than women (1.7 million, 45.9%). Johor comprises of
10 districts namely; Batu Pahat, Johor Bahru, Kluang, Kota Tinggi, Kulai, Mersing,
Muar, Pontian, Segamat and Tangkak. It consists of urban and semi urban areas.(318)
Figure 5.1 shows the 10 districts of Johor state.
186
Figure 5.1: Location of the ten districts in the state of Johor
There are a total of 88 health clinics or KKs in Johor which provide primary healthcare
services to its population.(334) Lack of diabetes intervention studies among KKs in
Malaysia necessitated the need to conduct the Phase Three research in multiple KKs.
A RCT method was selected to evaluate the effectiveness of pharmacist interventions
using the Simpler™ tool. This research was the first multicentre RCT to use a specific
method of diabetes intervention at KKs in the state of Johor and in Malaysia.
5.2 Objectives
The Phase Three research aimed to evaluate the impact of the tool’s application in
the management of T2DM patients through a RCT. The objectives of the Phase Three
research were to:
187
1. Evaluate the changes in patients’ clinical outcomes and cardiovascular risk
score at the end of a six-month period between the intervention arm and the
usual care arm.
2. Assess the impact of pharmacists’ interventions using the seven diabetes
factors namely:
• Statin/cholesterol control
• Insulin/glycaemic control
• Medication management
• Blood pressure control
• Lifestyle management
• Patient education
• CVD risk reduction strategies
3. Determine the impact of pharmacists’ interventions on patients’ QOL at the
end of the study period.
Phase Three tested the hypothesis that having a structured tool such as the Simpler™
tool would:
1. Result in reductions in HbA1c and blood glucose levels, blood pressure and
lipid measurements in the SC arm after six months compared to the control
group (SC vs UC).
2. Result in improved QOL scores between the arms at six months.
5.3 Methods
The Phase Three research was conducted between June 2016 and February 2017.
The research method was informed by the findings from Phases One and Two. Johor
state was chosen as the student researcher, SA, has previous work experience in a
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tertiary hospital in Johor Bahru. In addition, associate supervisor, SNMS has a role in
the management of clinical services provided in government hospitals and primary
healthcare clinics in Johor.
This was a two-arm prospective, parallel arm, RCT, multi-centre research study.
Participating sites were government funded primary healthcare clinics. Patients were
randomised to either the intervention arm with pharmacists using the Simpler™ tool
and providing Simpler™ care (SC), or the control arm with patients receiving usual
care (UC). Patients in the SC arm were followed up for a duration of six months by
pharmacists using the Simpler™ tool. Differences in clinical and QOL outcomes were
quantitatively measured pre-and post-intervention and between arms. The research
method followed the recommendations of the consolidated standards of reporting
trials (CONSORT) 2010 guideline for randomised trials.(335)
The research procedure had a specific protocol and documentation process for
participating pharmacists to follow which are explained in the following paragraphs.
A summary of the overall research process including the sections where explained, is
presented in Figure 5.2.
The Curtin University Human Research Ethics Committee (HREC) approved this
research (HR214/2015) as well as the Malaysian Medical Research and Ethics
Committee (NMRR-15-1831-28307) (refer to Appendices 5.1, 5.2 and 5.3).
Additionally, a nonexclusive, royalty-free licence was obtained to use the World
Health Organization QOL Questionnaire (WHOQOL-BREF) in three languages; English,
Bahasa Malaysia and Mandarin languages (Appendix 5.4).
As the research period for Phase Three fell during the Ramadan fasting month (June),
pharmacists were briefed on specific dose adjustment and timing in addition to
patient education on diabetes management during that period. As explained in
189
Section 5.1.3, pharmacist training on pharmacotherapy and patient education was
needed to prevent hypoglycaemia during the fasting period.
Figure 5.2: Flow diagram of the Phase Three research protocol
5.3.1.7 Evaluation tools
we
ek
1-2
7
5.3.1.1.Study Centres (n=11)
5.3.1.2 Pharmacist
recruitment (n=22)
Prin
cipal In
vestigato
rSim
ple
r™ train
ed
ph
armacists
5.3.1.3 Simpler™ training
Prin
cipal
Inve
stigator
5.3.2 Data collection
5.3.3 Data analysis
Intervention
(Week 1-27)
Control
(Week 1 & 27)
5.3.1.4 Patient recruitment
& randomisation
5.3.1.5 Intervention 5.3.1.6 Control
(n=60) (n=60)
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5.3.1 Recruitment process
5.3.1.1 Selection study centres
The study centres were government funded, outpatient primary health clinics (KK).
The eligibility criteria included KKs which provided MMS as part of its pharmacy
extended services and who employed two or more full time pharmacists who have
not been credentialed as diabetes pharmacists. Recruitment of the KKs was
conducted through personal contacts by the researcher (SA) and snowball
recruitment. Out of the 88 KK’s, the pharmacy managers of 11 KKs which fit the
eligibility criteria, expressed their willingness to participate in the research.
5.3.1.2 Pharmacist recruitment
The eligibility criteria for pharmacists included having less than three years of clinical
experience in diabetes management and having not undergone the credentialing
process to become a credentialed diabetes pharmacist by the Pharmaceutical
Services Division, Ministry of Health, Malaysia.
Pharmacists from the 11 KKs mentioned above were contacted by email and
telephone calls. In addition, the benefits of this research were explained to each
pharmacist to encourage their participation. An information sheet (Appendix 5.5)
and consent form (Appendix 5.6), with copies of ethics approvals were sent as
attachments. Pharmacists’ participation was voluntary and two pharmacists were
recruited from each KK to allow for pharmacist absences due to holidays, sickness or
other reasons.
Subsequently, permission to conduct research at each KK was sought from the
Deputy Director of Pharmaceutical Services Division of the State of Johor; and from
191
the Johor State Health Director. Letters to the Director of the Johor Health
Department (a copy sent to the Deputy Director of Johor Pharmaceutical Services
Division) are in Appendix 5.7. Additionally, an introductory letter was sent to the
managers of each of the KKs (Appendix 5.8). A letter of approval to conduct research
at the 11 KKs located in the seven districts by the Deputy Director of Johor
Pharmaceutical Services Division was obtained before the start of research (Appendix
5.9).
5.3.1.3 The Simpler™ training
Training commenced once the pharmacists signed consent forms to participate in the
research were received. Participating pharmacists completed two hours online
Simpler™ training validated and trialled in Phase Two. The training was completed
before the start of the trial. This was to ensure skills uniformity among the
pharmacists as suggested in previous literature.(135) All participants were briefed
on the protocol before the RCT commencement. The briefing took approximately
four hours and was conducted face-to-face in a predetermined venue in Johor Bahru,
Johor, Malaysia by SA. The agenda (Appendix 5.10) included an overview of the trial
protocol, practice session on documentation process and role play on the patient
recruitment procedure.
5.3.1.4 Patient recruitment and randomisation
The primary indicator was reduction of HbA1c ≥ 1% at the end of the study with
respect to the control arm. A power analysis using the DSS research sample size
calculator(336) indicated that at least 52 patients from each arm were needed. This
number of patients were required to show a mean HbA1c difference of -1.33%
between baseline and 6 months in the intervention arm compared to 0.4% for the
control arm. The standard deviation was 1.9. These data were selected for the
192
calculator based on findings from two previous studies conducted in the state of
Johor and Selangor, Malaysia.(128, 129) Based on these numbers, a sample of 60
patients for each arm (intervention and control) was calculated, allowing for a drop-
out rate of 15%.
The inclusion criteria for the patients were: T2DM diagnosis, aged > 21 years, on
multiple medications/co-morbidities, HbA1c > 8% (63.9 mmol/mol) or fasting blood
sugar > 7.0 mmol/L or two hours post prandial sugar level > 8.5 mmol/L.
The exclusion criteria were: if patients had been diagnosed with dementia or severe
psychotic illness, on haemodialysis treatment, pregnant or lactating, intended to be
pregnant within the next six months, diagnosed with cancer, or were involved in
other research at the time of recruitment. Patients who were previously recruited
into MMS such as the medication therapy adherence clinic (MTAC) diabetes prior to
the start of the trial were excluded. This was to prevent possibility of bias as patients
with previous exposure to MTAC diabetes may have increased knowledge of diabetes
self-management in comparison to other patients.
Patients were recruited during their scheduled visit to the doctor. Recruitment
processes were conducted either through proactively targeting patients who fulfilled
the inclusion criteria or through referral by diabetes nurses. The patients were seen
by the Simpler™ trained pharmacist prior to seeing the doctor. The Simpler™ trained
pharmacist provided participants the information sheet and a brief explanation
regarding the research. All patients were required to provide written consent and
were subsequently admitted to the intervention or control arm according to the
randomised schedule.
193
Patients were randomised to receive SC or UC using overall equal randomisation (1:1)
at each of selected sites. The randomisation numbers were predetermined by the
student researcher (SA) using an online random number generator based on a one
block randomised block design.(337) The patients were blinded to the randomisation
codes: intervention arm=1, control arm =2. Each KK were given a set of 24 sealed
brown envelopes each containing a code and were labelled with continuous
numbering of patient identification number. Whilst the patients were blinded the
pharmacists were not and the pharmacists opened the envelopes in ascending order
and depending on the randomisation code allocated patients to either the
intervention or control arms. Figure 5.3 provides a summary of the steps involved.
194
*WHOQOL-BREF=abbreviated quality of life questionnaire developed through the World Health Organization
Figure 5.3: Flow diagram of the process involved in the intervention and control
arms
File all documentation (separate file for each patient)
Patient consent form Simpler™ Pro forma
Patient follow up for intervention arm
Patient has doctor's appointment
•Record intervention in the Simpler™ Pro Forma A
Patient has NO doctor's appointment
•Record interventions in the Simpler™ Pro Forma B
Pharmacist opens sealed envelope. Patients are randomised accordingly
Intervention arm (SC)
•Nurses, pharmacists and doctors record data in the Simpler™ Pro Forma
•Patient to complete *WHOQOL-BREF
•Make appointments for follow up visits 2-6 until week 27
Control arm (UC)
•Collect patient demographics and laboratory data
•Patient to complete *WHOQOL BREF questionnaire
•Make appointments for week 27 only
Pharmacist access patients and recruit according to eligibility criteria
Meet inclusion criteria Meet exclusion criteria
195
5.3.1.5 Intervention (SC) arm
Patients in the intervention (SC) arm received usual care like patients in the control
(UC) arm. In addition, they received a minimum of 20-30 minutes’ face-to-face
interview with the intervention pharmacist prior to seeing the doctor. During this
interview the pharmacist utilised the Simpler™ tool to deliver pharmaceutical care.
Pharmacists utilised information gathered from patients and retrieved from medical
records to make an assessment. Subsequently, by using the Simpler™ tool, they
documented their interventions and individual goals for patients in the Simpler™ Pro
Forma A and B (Appendix 5.11 and 5.12) and these were evaluated at each following
visit. Simpler™ Pro Forma A was used on days when patients had appointment with
doctor and nurse. The Simpler™ Pro Forma forms were then attached to patients’
medical notes. The doctors were encouraged to record their interventions on the
same forms. In most public health institutions in Malaysia, doctors would use black
while nurses use blue ink. To differentiate each healthcare professionals’
intervention, pharmacists used purple ink. Pharmacists then captured an image of
each completed Simpler™ Pro Forma and sent it to the researcher, SA, through email
once every month.
The Simpler™ Pro Forma B was used on days when patients had appointment with
pharmacist only. During that time, pharmacists had autonomy to titrate insulin doses
up to two units at each follow up visit for patients who do achieve the therapeutic
target. In addition, pharmacists informed the doctors on any therapy change
required and their recommendations. Subsequently, all interventions were
documented using the Simpler Pro Forma B.
Patients were seen in a private consultation room located near doctors’ consultation
rooms when they had doctors’ appointments and at a private counselling area at the
196
pharmacy when they did not have a doctor’s appointment. An audit was performed
on completed Simpler™ Pro Forma by SA to ensure the required information were
recorded. In addition, current diabetes management information was sent to
pharmacies periodically to keep them informed on recent developments.
In addition, patients completed the WHOQOL-BREF questionnaire once at the start
(visit 1) and once at the end (visit 6) (Appendix 5.13, 5.14, 5.15). An image or scanned
copy of the completed questionnaire for each visit was sent to the researcher.
Pharmacists scheduled monthly appointments (five more times) for patients until the
end of the trial (week 27). Additionally, pharmacists called patients the day before
the appointment to remind them of their visit with the pharmacist.
The key tool used in the intervention arm was the previously developed and
evaluated Simpler™ tool which consisted of the seven evidence-based factors from
diabetes clinical practice guidelines. Each pharmacist received the Simpler™ tool
resource pack which consisted of a number of resources as shown in Table 5.2.
197
Table 5.2: Simpler™ tool resource pack contents
No. Item Appendix
1. Simpler Pro Forma A (when patient has a doctor’s appointment)
Appendix 5.11
2. Simpler Pro Forma B (when patient has no doctor’s appointment)
Appendix 5.12
3. WHOQOL-BREF questionnaire (Bahasa Malaysia, English and Mandarin)
Appendix 5.13, 5.14, 5.15
4. Patient information sheet and consent forms in Bahasa Malaysia English languages
Appendix 5.16,5.17,5.18,5.19
5. 8-item MMMAS in English and Bahasa Malaysia languages.(1)
Appendix 5.20 and 5.21
6. Naranjo probability scale for adverse drug reaction(338) Appendix 5.22
7. Researcher data collection form Appendix 5.23
8. Simpler™ tool hand-out Appendix 5.24
9. For patients use Appointment booklets for patients, SMBG record booklet and empty pocket files for each patient
Not applicable
10. Stationery for pharmacists’ use Stationery such as purple coloured pens and stapler. Folder containing hand-outs on Simpler™ training module; Simpler™ hand-out; oral hypoglycaemic and insulin treatment algorithm; efficacy and side effects profile of oral hypoglycaemic medicines; potential drug interactions, sealed brown envelopes containing information on participant ID and the arm they will be randomised
Not applicable
11. Monitoring device for pharmacists Blood pressure monitor and tape measure to measure patient’s waist circumference
Not applicable
8-item MMMAS=eight item modified Morisky medication adherence scale; SMBG=self-monitoring of blood glucose; WHOQOL-BREF=abbreviated quality of life questionnaire developed through the World Health Organization;
5.3.1.6 Control arm
Patients in the control arm received the usual care (UC). The routine medical care of
patients with diabetes at primary health clinics in Malaysia consist of patient-doctor-
nurse visits that ranges from between three to five visits per year. The role of the
nurse is to take the blood glucose and blood pressure measurements. In addition,
nurses record the height and weight of the patient and provide diabetes education
to patients who have not achieved glycaemic control. It is also the nurse’s
198
responsibility to schedule the patient’s appointment with the doctor and organise
laboratory tests as ordered by the doctor. In addition, patients received usual
pharmacy care which includes monthly medication refills and patient counselling to
promote safe and effective medicine use.
The number of scheduled doctors’ appointments throughout the duration of this trial
was the same for the both arms. As described above, they were seen once at the
beginning of the trial (baseline) by research pharmacists to record baseline data.
Subsequently, UC patients will continue their usual care with no other intervention.
Pharmacist scheduled an appointment for patients to be seen once more at week 27
to record exit data. Similar to the SC arm, patients in the UC arm also completed the
WHOQOL-BREF questionnaire once at the start (week 1) and once at the end (week
27). An image or scanned copy of patient demographics, laboratory data and
completed WHOQOL BREF questionnaires were sent to the researcher.
5.3.1.7 Evaluation tools
Intervention pharmacists used the evaluation tools to record interactions with
patients, assess medication management issues and measure blood pressure and
glucose and waist circumference, both for when patients had doctors’ appointments
and during patients’ visits to the pharmacy for prescription refills in-between doctors’
appointments. The evaluation tools were therefore used in SC patients from weeks
1 to 27 but were only used for UC patients at the start (week 1) and the end (week
27) of the study.
Pharmacists performed blood pressure (BP) measurements using OMRON HEM/120
arm blood pressure monitors, blood glucose measurements using Abbott Freestyle
Optiums and waist circumference measurements on patients during each visit. The
BP monitor was procured by SA (part of the Scott Kimpton award for fieldwork
199
research) and was provided to pharmacists as part of their participation in the study.
Pharmacists used the existing blood glucose monitors provided by their respective
KKs. In addition to government funded and managed laboratories, HbA1c
measurements were performed by a registered private laboratory, Pathlab
(Pathology & Clinical Laboratory (M) Sdn.Bhd). WHOQOL-BREF questionnaires were
self-administered. The primary and secondary outcome variables measured in this
trial are shown in Table 5.3.
Table 5.3: Primary and secondary outcome variables measured at baseline and for
the subsequent six months
Simpler™ factor evaluated
Variable Evaluation Tools
Primary outcome variables
Insulin/glycaemic Glycaemic control HbA1c measured at visit 1 and at visit 6 at hospital or private laboratory.
Secondary outcome variables
Insulin/glycaemic Glycaemic control FBG measurement by pharmacist at each visit
BP BP Measurement by pharmacist at each visit. Measured twice. Third measurement taken only when the first two readings are different by more than 10mmHg and 6mmHg for systolic and diastolic BP.
Medication Medication adherence
8-item MMMAS administered by pharmacists.
Statin/cholesterol Blood lipids measured at visit 1 and at visit 6 at hospital or private laboratory
Lifestyle BMI Calculated from height and weight measured by pharmacist during doctor’s visit
Lifestyle Waist circumference Measured by pharmacist
Lifestyle Physical activity Self-reported by patient
Lifestyle Health related QOL WHOQOL-BREF questionnaire administered by pharmacist at week 1 and week 27
CVD risk FRS Using online calculator for risk score calculation using patients’ BMI and lipid results at each visit.(89)
All factors Pharmacists’ interventions as per the Simpler™ tool
All interventions recorded in the Simpler™ Pro Forma A and B
BMI=body mass index; BP=blood pressure; FRS=Framingham risk score; HbA1c= glycated haemoglobin; MMMAS= modified Morisky medication adherence scale; SMBG=self-monitoring of blood glucose; QOL=quality of life; WHOQOL-BREF= abbreviated quality of life scale developed through World Health Organization;
200
5.3.2 Data collection
Sociodemographic information such as age, gender, ethnic origin, number of
comorbidities, employment and education level were obtained through Simpler™ Pro
Forma A and B forms for the SC arm and from medical notes and patient interviews
for the UC arm. Information on patients’ medication and laboratory results were
obtained from patient medical records for both arms.
As mentioned previously, images sent by pharmacist were scrutinised by the
researcher (SA) for missing information. Pharmacists were then contacted to obtain
the required missing information. A data collection form (see Appendix 5.22) was
used to record all required information.
5.3.3 Data analysis
Data analysis was performed on primary and secondary outcomes variables as
outlined in Table 5.3. Information from the data collection forms mentioned in
Section 5.3.2. were transferred into the IBM Statistical Package for Social Sciences
(SPSS) software version 22.(233) An excerpt of the data from SPSS is shown in
Appendix 5.25. The data were then analysed using the same statistical program.
Outcomes from the intervention and control arms were compared at baseline using
independent t-tests for parametric data and Mann-Whitney U-test for non-
parametric data. Pearson chi-square test was used for categorical parameters.
Paired t-test was used to detect significant differences at baseline and at 6 months.
Occasionally one-way analysis of variance (Anova) was used to determine significant
differences between three or more categories. An alpha level of ≤ 0.05 was used for
all statistical tests to denote significance level.
201
5.4 Results
Prior to the start of the trial, 11 KKs expressed their willingness to participate. One
of the pharmacists from one of the KKs who commenced training was a credentialed
diabetes pharmacist which did not conform to the eligibility criteria for pharmacists.
Three KKs withdrew due to staff shortages and increasing workload. Therefore, only
pharmacists from the remaining seven KK’s signed the consent form.
All participating pharmacists were trained on diabetes management and medication-
related interventions using the Simpler™ tool. The online training session ran from
mid-April to end May 2016. On completion, pharmacists were invited to a four-hour
face to face RCT briefing session held in Johor Bahru, Malaysia. Depending on
pharmacist availability, pharmacists were given an option to attend the briefing
session on separate dates. Seven pharmacists attended the briefing on 4th June 2016
while five attended the briefing on 11th June 2016. One pharmacist could not attend
on both dates and was therefore briefed at his normal place of work on 23rd June
2016 and the 14th pharmacist was trained at a later date (7th February 2017). The
RCT commenced in mid-June 2016 and was completed by early March 2017.
5.4.1 Demographic characteristics of pharmacists
There was a total of 14 pharmacists who were initially recruited. One pharmacist
dropped out during the research because she was relocated to another pharmacy,
therefore the new pharmacist who replaced her in that clinic was conveniently
recruited and trained. Hence, 14 pharmacists were recruited and trained in total.
Pharmacists recruited worked in seven KKs situated in six out of the total 10 different
districts in the state of Johor. The names of the KKs were: Bukit Besar and Bandar
202
Tenggara in the Kota Tinggi district; Tenggaroh 2 in the Mersing district; Bukit Pasir in
the Muar district; Paya Mas in the Tangkak district; Segamat in the Segamat district;
and Tebrau in the Johor Bahru district. A map of Johor state in Figure 5.4 marks the
location of each participating site (KK), showing that the sites were spread
throughout the state and hence represented a wide geographical area.
Figure 5.4: Location of participating sites in the state of Johor, Malaysia using
Google maps.(339)
The majority of the participating pharmacists were female (12/14; 85.7%). All
pharmacists worked full time and on average 37.5 hours per week. Half of the
pharmacists (7/14; 50%) recruited were practicing pharmacists for a period of less
than 3 years. None of the pharmacists had been credentialed or received any formal
diabetes training. Most pharmacists (10/14; 71.4%) had been conducting diabetes
management services for less than one year. Collectively all pharmacists had less
Tenggaroh 2
Tebrau
Segamat
Bukit Besar
Bandar Tenggara
Bukit Pasir Payamas
203
than three years’ experience in the management of T2DM patients. Table 5.4
presents pharmacists’ practice experience.
Table 5.4: Participating pharmacists practice experience (years)
Years qualified Number of pharmacists n (%)
0-1 2 (14.3)
>1 and <3 5 (35.7)
3-5 3 (21.4)
>5 4 (28.6)
Total 14 (100)
Years of conducting diabetes MMS
Number of pharmacists n (%)
0-1 10 (71.4)
>1 and <3 4 (28.6)
Total 14 (100)
Pharmacists were asked to rank the main motivating factors that induced their
participation in this research. The two main reasons that were ranked in the upper
quartile range of the Likert scale (4 and 5) were “improve patients’ outcome” (13/14;
92.9%) and “interested in subject” (9/14; 64.3%) as shown in Figure 5.5. The other
factors which got the highest rankings (4 and 5) are also presented.
204
Figure 5.5: Factors that motivated pharmacists to participate in Phase Three
research
5.4.2 Results from pre-and post-training questionnaire
Overall there was significant improvement in the post-test results compared to the
pre-test (p=0.001). The median pre-test score for the 1st and 2nd markers was 5.75
(IqR 3.6) out of 27. The median post-test score for the 1st marker and 2nd marker was
14.29 out of 27 marks. The statistical results are presented in Table 5.5.
0
10
20
30
40
50
60
70
80
90
100
Financialreward
Continuingprofessionaldevelopment
Recommendedto me
Interested indiabetes
Improvepatients'outcome
Pe
rcen
tage
of
ph
arm
acis
ts
Motivation factors
205
Table 5 5: Pharmacists pre- and post-training scores of participants (n=14)
Median (IqR) Z stat ap value
Pre-test Post-test
Test score (1st marker) 5.5 (3.8) 14 (5.3) -3.303 b0.001
Test score (2nd marker) 6.0 (4.3) 13.5 (4.8) -3.193 b0.001
(1st and 2nd marker) 5.75 (3.6) 13.25 (4.1) -3.299 b0.001
astatistical test using Wilcoxon signed rank test for non-parametric data; bstatistically significant
5.4.3 Demographic characteristics of patients
A total of 154 T2DM patients (77 SC: 77 UC) attending the seven KKs were recruited
into the study. Table 5.6 shows the number of patients recruited from each KK and
the numbers excluded from the final analysis.
There were 89.6% (69/77) of patients in the UC arm who completed the study.
Reasons for non-completion included patients absent on follow up visits despite
repeated reminders and telephone calls, patients did not have outcome measures or
passed away.
In the SC arm, 79.2% (61/77) patients completed the study. The average number of
visits to the pharmacists was 5 (SD=1.43). The number of visits ranged from two to
six visits for each patient. Each visit lasted between 20 and 30 minutes. However
only the 55 patients out of the total 61 patients who attended a minimum of three
visits (55/77; 71.4%) were included in data analysis. The reasons why patients
completed less than the agreed six visits were, not able to meet at predetermined
dates agreed with pharmacists. In other instances, pharmacists were not able see
patients due to heavy dispensing workloads caused by lack of staffing.
206
Table 5.6: Number of patients recruited and number of dropouts from each KK
KK No. patients recruited (%)
No. patients dropped out (%)
No. patients’ data used in analysis for
final visit (%)
SC UC SC UC SC UC
Bukit Besar 12 (15.6) 12 (15.6) 0 0 12 (21.8) 12 (17.4)
Bandar Tenggara
12 (15.6) 12 (15.6) 5 (22.7) 1 (12.5) 7 (12.7) 11 (15.9)
Bukit Pasir 12 (15.6) 12 (15.6) 0 0 12 (21.8) 12 (17.4)
Paya Mas 12 (15.6) 12 (15.6) 6 (27.3) 5 (62.5) 6 (10.9) 7 (10.1)
Segamat 12 (15.6) 12 (15.6) 1 (4.5) 0 11 (20.0) 12 (17.4)
Tebrau 5 (6.5) 5 (6.5) 2 (9.1) 2 (25.0) 3 (5.5) 3 (4.3)
Tenggaroh 2 12 (15.6) 12 (15.6) 8 (36.4) 0 4 (7.3) 12 (17.4)
Total 77 (100) 77 (100) 22 (100) 8 (100) 55 (100) 69 (100)
For the purpose of this research, the HbA1c values are expressed in the International
Federal Clinical Chemistry Working Group (IFCC-WG) unit as mmol/mol and are used
interchangeably with National Glycohaemoglobin Standarization Program (NGSP)
unit as %.(340)
Figure 5.6 presents the CONSORT(341) diagram illustrating the flow chart of the
research participants from enrolment to final analysis.
207
Assessed for eligibility (n=160)
Excluded (n= 6)
• Not meeting inclusion
criteria of HbA1c>8% (63.9
mmol/mol) or FBS > 7.0
mmol/L or 2hrPPG level >
8.5 mmol/L. (n= 6)
Analysed (n=69)
Lost to follow-up (n=8)
Unable to be contacted therefore
did not complete visit 6 = 7
Passed away=1
Allocated to control (n=77)
• Received allocated
intervention (n= 77)
Lost to follow-up (n=16)
Unable to be contacted
therefore did not complete visit
6 = 16
Allocated to intervention (n=77)
• Received allocated
intervention (n= 77)
Analysed (n= 55)
• completed 3-6 visits
• Excluded from analysis:
Patients completed only 2
visits=6
Allocation
Analysis
Follow-Up
Randomised (n=154)
Enrolment
Figure 5.6: CONSORT diagram of patients’ recruitment and completion.
208
There were six patients in the SC arm who completed only two visits to the pharmacy.
Appendix 5.26 presents the demographic data of the six patients who completed only
two visits. As stated, the analysis of results in this chapter included data for SC
patients who completed the study and who attended a minimum of three visits. A
required minimum of three visits to pharmacists was agreed by the research team as
this allowed patient education on various aspects of diabetes medication and self-
management throughout the trial period. Table 5.7 presents the breakdown of
number of patients and their completed number of visits to pharmacists.
Table 5.7: Breakdown of SC patients who completed the three to six visits with
the pharmacist
No. visits with pharmacists No. SC patients (%)
3 7 (12.7)
4 7 (12.7)
5 7 (12.7)
6 34 (61.8)
Total 55 (100)
The baseline characteristics of patients in the SC and UC arms are shown in Table 5.8.
A comparison of SC and UC patients with respect to demographic, family history,
types and number of comorbidities and current employment showed no significant
differences. The mean age from both arms were 56.5 years and there were more
female patients recruited in comparison to male patients. Ethnic Melayu patients
outnumbered other races in both arms and hypertension was the most identified
comorbidity. There were slightly more patients in the SC arm who were working
(52.7%) compared to the UC arm but this difference was not significant. There was a
significant difference between patients’ overall highest education level between the
209
SC and UC arms. Nevertheless, the percentage of patients who were educated and
those who were not did not differ among SC and UC arms (p=1.000).
210
Table 5.8: Baseline characteristics of the study population
Characteristics SC (n=55)
UC (n=69)
p-value
Mean age (years) 55 (SD=8.9) 58 (SD=10) 0.068
Existing family history of diabetes
29 (53.7%) 21 (38.2%) 0.106
Gender 0.854
Female 32 (58.2%) 39 (56.5%)
Male 23 (41.8%) 30 (43.5%)
Ethnic origin 0.837 aMelayu 43 (78.2%) 53(76.8%)
Chinese 8 (14.5%) 11 (15.9%)
Indian 4 (7.3%) 5 (7.2%)
Comorbidities
Hypertension 49(76.6%) 61 (69.3%) 0.905
CVD 1 (1.6%) 1 (1.1%)
Nephropathy 5 (7.8%) 12 (13.6%) 0.182
Retinopathy 3 (4.7%) 3 (3.4%)
Neuropathy 3 (4.7%) 1 (1.1%)
≥2 comorbidities 12 (21.8%) 21 (30.4%) 0.393
Highest education level b0.028
Primary 10 (18.2%) 29 (42.0%)
Secondary 34 (61.8%) 34 (49.3%)
Diploma 6 (10.9%) 3 (4.3%)
University 3 (5.5%) 1 (1.4%)
Not educated 2 (3.6%) 2 (2.9%)
Current employment 0.080
Caring for family 18 (32.7%) 34 (49.3%)
Working 28 (50.9%)) 30 (43.5%)
Unemployed 2(3.6%) 0 (0%)
Retired 7 (12.7%) 5 (7.2%)
Clinical parameter SC mean (SD) UC mean (SD) p-value
HbA1c (%)/(mmol/mol) 10.68/93 (2.22) 10.32/89 (1.50) 0.337
Systolic BP (mmHg) 136.97(16.78) 137.82 (18.33) 0.791
Diastolic BP (mmHg) 80.95(12.00) 79.87 (10.47) 0.592
LDL (mmol/L) 3.09(1.13) 3.35 (1.16) 0.317
HDL (mmol/L) 1.28(0.34) 1.19 (0.24) 0.158
TG (mmol/L) 1.93(1.23) 1.97 (0.92) 0.870
Creatinine (mmol/L) 78.46(24.20) 80.74 (25.11) 0.657
BMI (kg/m2) 28.82 (5.43) 29.32 (5.26) 0.606
Waist circumference (cm) 96.51(11.31) 95.78 (10.71) 0.717 a Melayu refers to ethnic Malay and indigenous population in Malaysia bChi-square and Fisher’s exact tests was used to determine significance, denoted as p<0.05, between intervention (SC) and usual care (UC) arms.
BP=blood pressure; BMI=body mass index; CVD=cardiovascular disease; HbA1c= haemoglobin A1c; LDL=low density lipoprotein; HDL=high density lipoprotein; SD=standard deviation; TG=triglyceride
211
5.4.4 Medication use at baseline and changes at six months
The average number and types of medication used by patients in both arms are
presented in Table 5.9. Patients’ medication lists included mostly antidiabetic,
antihypertensive and lipid lowering medicines and a daily antiplatelet medication.
The changes at 6 months from baseline were not statistically different between the
two arms except for a daily antiplatelet as primary prevention to decrease CVD risk
(p=0.02). Other medications used related to patients’ other comorbidities as shown
in Table 5.10. The other medications at the final visit were mostly vitamin B complex
(SC=24% vs UC=20%).
At 6 months, 72.7% of SC patients were prescribed metformin compared to 61.8% of
patients at baseline. There was a slight increase in the number of patients on
metformin at 6 months for both SC (10.7%) and UC arms (6%). However, these
differences between arms were not statistically significant between baseline
(p=0.408) and at 6 months (p=0.337). Similarly, there was no significant difference in
the number of prescribed insulin between arms at 6 months, (p=0.414). The SC arm
had a non-significant increase (5.4%) in the number of patients on prescribed insulin
at 6 months compared to baseline, while the UC arm initiated two patients on insulin,
a non-significant increase of 2.9% at 6 months from baseline. Of interest, the SC arm
had a higher proportion of patients (74.5%) on insulin as required by the Malaysian
diabetes guidelines when compared to UC arm (72.5%).
Pharmacist interventions on ACEI/ARB initiation contributed to a slight increase
(11%) in prescribed ACEI/ARB for the SC arm at the end of the study at 6 months,
however, this increase was not statistically significant (baseline vs 6 months). Equally,
UC patients had a non-significant increase (12.5%) of prescribed ACEI/ARB at 6
months.
212
Table 5.9: Medication use and changes over six months in SC and UC arms
SC (n=55)
n (%) UC (n=69)
n (%) SC vs UC ap-value
Baseline 6 months Baseline 6 months Baseline 6 months
Use of Insulin 0.51 0.41
Short 5 (9.1) 6 (10.9) 11 (15.9) 13 (18.8)
Intermediate 18 (32.7) 20 (36.4) 21 (30.4) 23 (33.3)
Long 1 (1.8) 2 (3.6) 2 (2.9) 0
Premixed 19 (34.5) 19 (34.5) 25 (37.7) 28 (40.6)
OHA
Metformin 34 (61.8) 40 (72.7) 40 (58.0) 44 (63.8) 0.41 0.33
Sulphonylurea 15 (27.3) 15 (27.3) 18 (26.1) 17 (24.6)
Metformin+sulphonylurea 11 (20.0) 9 (16.4) 12 (17.4) 9 (13.0)
Acarbose 1 (1.8) 3 (5.5) 3 (4.3) 4 (5.8)
DPP-4 Inhibitor 0 0 1 (1.4) 1 (1.4)
SGLT-2 Inhibitor 0 1 (1.8) 0 0
Antihypertensive
ACEI 35 (63.6) 38 (69.1) 37 (53.6) 41 (59.4) 0.40 0.29
ARB 1 (1.8) 2 (3.6) 3 (4.3) 4 (5.8)
CCB 30 (54.5) 31 (56.4) 40 (58.0) 44 (63.8)
Beta blocker 8 (14.5) 9 (16.4) 14 (20.3) 16 (23.2)
Alpha blocker 3 (5.5) 3 (5.5) 3 (4.3) 4 (5.8)
Diuretic 15 (27.3) 13 (23.6) 15 (21.7) 14 (20.3)
Coversyl Plus (Perindopril+indapamide)
0 0 1 (1.4) 0
Lipid lowering
Simvastatin 44 (80.0) 47 (85.5) 52 (75.4) 52 (75.4) 0.43 0.12
Others 3 (5.5) 3 (5.5) 4 (5.8) 4 (5.8)
213
SC (n=55)
n (%) UC (n=69)
n (%) SC vs UC ap-value
Baseline 6 months Baseline 6 months Baseline 6 months
Daily antiplatelet
Aspirin 16 (29.1) 22 (40.0) 15 (21.7) 16 (23.2) 0.25 b0.02
Ticlopidine 1 (1.8) 2 (3.6) 0 0 ap-value from Pearson chi-square test; b statistically significant ACEI=angiotensin converting enzyme inhibitor; ARB=angiotensin renin blocker; CCB=calcium channel blocker; DPP-4 inhibitor=dipeptidyl -4 inhibitor; OHA=oral hypoglycaemic agent; SC=Simpler ™ care intervention; SLGT2=sodium glucose cotransporter-2; UC=usual care
214
Table 5.10: Other medication used by patients in both SC and UC arms
SC (n=55)
n (%) UC (n=69)
n (%)
Baseline 6 months Baseline 6 months
Inhalers for asthma 2 (3.6) 2 (3.6) 2 (2.9) 2 (2.9)
Allopurinol 0 0 0 1 (1.4)
Calcium carbonate 1 (1.8) 0 0 0
Empagliflozin 0 2 (3.6) 0 0
Glyceryl trinitrate 1 (1.8) 2 (3.6) 2 (2.9) 3 (4.3)
Isosorbide mononitrate 1 (1.8) 2 (3.6) 3 (4.3) 4 (5.8)
L-thyroxine 0 0 1 (1.4) 0
Omeprazole 1 (1.8) 0 1 (1.4) 1 (1.4)
Potassium chloride 0 0 3 (4.3) 3 (4.3)
Ranitidine 4 (7.3) 4 (7.3) 1(1.4) 1 (1.4)
Vitamin B complex 10 (18.2) 13 (23.6) 11 (15.9) 13 (18.8)
Traditional medications 4 (7.3) 1 (1.8) - - SC=Simpler™ care intervention; UC= usual care; n=sample size
215
5.4.5 Doctor’s visits and hospital admissions at 6 months
There was a total of five hospital admissions during the six months’ study period. Two
hospital admissions in the SC arm and three hospital admissions in the UC arm.
Although the UC arm had one more hospital admission than the SC arm, this
difference was not statistically significant (p=0.868).
Similarly, there was no significant difference between the average number of
patients’ visits to doctors between the SC (2.73; SD=0.971) and UC arm (2.75;
SD=1.322; p=0.902). The frequency of visits to the doctor in the SC and UC arm is
presented graphically in Figure 5.7.
Figure 5.7: Comparison of patients’ visits to the doctor for SC and UC arms
5.4.6 Pharmacists’ interventions
The number of patients in the SC arm whom interventions were recorded over the 6
month follow up is shown in Table 5.11. SC pharmacists managed to address all the
0
10
20
30
40
50
60
1 2 3 ≥4
Percentage of patients
Number of visits
No. patients (%) SC
No. patients (%) UC
216
indicators in most patients (>60%) in the SC arm. The number of patients who
achieved treatment targets according to the guidelines(6) is discussed separately in
section: 5.4.7.1.
217
Table 5.11: Simpler™ interventions conducted on SC patients over the 6 months follow up
Indicators No.patients (%) (n= 55)
Yes (%) No (%) Not relevant (%)
S=Statin
Statin initiation in patients with CVD 13 (23.6) 0 42 (76.4)
Achieve targets: LDL<2.6 mmol/L, TG<1.7 mmol/L See Table 5.13
Statin initiation in patients > 40 years old without CVD 38 (69.1) 0 17 (30.9)
I=Insulin/Glycaemic control
Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
41 (74.6) 14 (25.5) 0
Target of HbA1c ≤ 7% (53mmol/mol) if no other complications See Table 5.13
Management of hypoglycaemia 48 (87.3) 7 (12.7) 0
Self-monitoring of blood glucose 51 (92.7) 4 (7.3) 0
Aim a difference for HbA1c of -1% if above target HbA1c See Table 5.13
Initiate/continue metformin if not contraindicated 50 (90.9) 4 (7.3) 1 (1.8)
M=Medication
Assess medicine related problems 55 (100) 0 0
Review medication adherence using 8-items MMMAS 55 (100) 0 0
P= Blood pressure
218
Indicators No.patients (%) (n= 55)
Yes (%) No (%) Not relevant (%)
Achieve BP target ≤135/75 See Table 5.13
ACE-I/ARB initiation in patients with/without microalbuminuria /proteinuria 45 (81.8) 6 (10.9) 4 (7.3)
Reduce sodium intake (<2400mg sodium/day; 6g/1 teaspoon/day) 51 (92.7) 4 (7.3) 0
Take one or more antihypertensive at bedtime 37 (67.3) 13 (23.6) 5 (9.1)
L=Lifestyle
Exercise: 30 mins walking (or equivalent) 5 or more days/week (total ≥ 150 min/week)
See Table 5.13
Weight loss: BMI ≤ 23kg/m2 See Table 5.13
Advise on smoking cessation 5 (9.1) 0 50 (90.9)
Waist circumference: ≤ 90cm in men, ≤ 80cm in women See Table 5.13
Alcohol intake: ≤2 standard drinks (20 g) per day for men 54 (98.2) 1 (1.8) 0
Management of stress and diabetes related distress 35 (63.6) 20 (36.4) 0
Erectile dysfunction: recommend PDE-5 inhibitor as first line therapy for male patients
55(100)
Foot care 47 (85.5) 8 (14.5) 0
Diet advice using plate model 51 (92.7) 4 (7.3) 0
Annual eye assessment 39 (70.9) 16 (29.1) 0
Address sleep hygiene 40 (72.7) 15 (27.3) 0
219
Indicators No.patients (%) (n= 55)
Yes (%) No (%) Not relevant (%)
E=Education
Knowledge and understanding of medicine 55 (100) 0 0
Medicine storage 52 (94.6) 3(5.5) 0
Medication optimisation during fasting month for Muslims and other religious arms
1 (1.8) 0 54 (98.2)
R= CVD risk
Aspirin therapy as secondary prevention in those with diabetes with history of CVD
37 (67.3) 6 (10.9) 12 (21.8)
Use of Framingham risk calculator to calculate CVD risk and educate patients 39 (70.9) 16 (29.1) 0
Aspirin therapy (75mg-162mg/day) as primary prevention to decrease CVD risk (10-year risk>10%, Framingham) (patients >65 years old)
37 (67.3) 5 (9.1) 13(23.6)
ACEI=angiotensin converting enzyme inhibitor; ARB=angiotensin renin blocker; BMI= body mass index; CVD= cardiovascular disease HbA1c= haemoglobin A1c; BMI=body
mass index; BP=blood pressure; TG=triglyceride; LDL=low density lipoprotein; MMMAS= modified Morisky medication adherence scale; HDL=high density lipoprotein
220
5.4.7 Clinical outcomes of patients in both arms
Table 5.12 presents the results of the statistical test analyses of patients between the
SC and UC arms and at baseline and at 6 months’ intervention. Results show
significant improvement in HbA1c (p=<0.001) and systolic BP (p=0.028) at 6 months
between arms. The effect size for HbA1c differences in this research is 0.702 for
Cohen’s d and 0.722 for Hedges’g.
The SC arm showed significant differences in HbA1c and systolic BP at 6 months
compared to the UC arm. In this study, a separate analysis was done for each variable
in Table 5.12. These variables were not dependent on each other therefore
Bonferroni adjustments were not applicable. This is in accordance to suggestions by
Perneger.(342)
The number of patients who achieved treatment targets at 6 months according to
the Malaysian diabetes guidelines is shown in Table 5.13. More patients in the SC
arm achieved the treatment targets compared to the UC arm for all clinical
parameters listed except for diastolic BP. However, only the number of patients who
achieved the treatment targets for HbA1c, LDL and systolic BP were significantly
different between the two arms.
221
Table 5.12: Clinical parameters of participants at baseline and on 6 months follow up in SC and UC arms
Variables SC vs UC n Baseline Mean (SD)
6 months Mean (SD)
Mean difference (95% CI)
Baseline vs 6- months ap-value
SC vs UC (6 months) bp-value
HbA1c (%)/mmol/mol
SC 49 10.68/93 (2.22) 9.08/76 (2.26) -1.59 (-2.2 to -0.9) c <0.001 c <0.001
UC 63 10.32/89 (1.50) 10.07/86 (1.80) -0.25 (-0.62 to 0.11) 0.171
BMI (kg/m2) SC 55 28.82 (5.43) 28.72 (5.33) -0.1 (-0.6 to 0.4) 0.710 0.481
UC 68 29.32 (5.26) 29.52 (5.22) 0.20 (-0.4 to 0.8) 0.529
Waist circumference (cm)
SC 54 96.51(11.31) 95.02(8.84) -1.49(-3.6 to 0.6) 0.164 0.249
UC 65 95.78 (10.71) 95.71 (11.17) -0.06 (-1.44 to 1.31) 0.928
Systolic BP (mmHg) SC 55 136.97(16.78) 130.68(14.35) -6.28(-10.5 to -2.0) c 0.005 c 0.028
UC 69 137.82 (18.33) 138.07(13.35) 0.26 (-3.74 to 0.43 ) 0.897
Diastolic BP (mmHg) SC 55 80.95(12.00) 78.49(9.65) -2.46(-5.8 to -0.8) 0.141 0.705
UC 69 79.87 (10.47) 78.21 (9.15) -1.66 (-4.37 to 1.05) 0.225
Total Cholesterol (mmol/ml)
SC 44 5.19(1.25) 5.02 (1.19) -0.17(-0.6 to 0.3) 0.419 0.943
UC 53 5.36 (1.30) 5.21(1.43) -0.15 (-0.5 to 0.2) 0.373
TG (mmol/ml) SC 44 1.93(1.23) 1.67(0.94) -0.26(-0.6 to 0.1) 0.138 0.202
UC 54 1.97 (0.92) 1.99 (1.15) 0.03 (-0.26 to 0.31) 0.856
LDL (mmol/ml) SC 38 3.09(1.13) 2.61(1.09) -0.49(-0.9 to -0.1) c 0.017 0.553
UC 49 3.35 (1.16) 3.01 (1.25) -0.33(-0.68 to 0.012) 0.058
HDL (mmol/ml) SC 37 1.28(0.34) 1.40(0.39) 0.12 (1.2 to 2.3) c 0.010 0.598
UC 50 1.19 (0.24) 1.28 (0.30) 0.09 (0.012 to 0.17) c 0.024 ap values from paired t-test. Changes over 6 months are mean difference (95% CI); bp values from independent t-test; cstatistically significant SC=Simpler™ care; UC= Usual care; SD=standard deviation; CI= confidence interval; HbA1c= haemoglobin A1c; BMI=body mass index; BP=blood pressure; TG=triglyceride; LDL=low density lipoprotein; HDL=high density lipoprotein
222
Table 5.13: Comparison of participants in SC and UC arms who met treatment target
at 6 months according to the 2015 Malaysian clinical practice guidelines on of
T2DM.(6)
Variables Arm n Total patients (%)
ap-value
SC vs UC
HbA1c ≤ 6.5%/48mmol/mol SC 49 7(14.3) c 0.020
UC 65 1(1.5)
BMI ≤ 23 kg/m2 SC 55 7 (12.7) 0.484
UC 68 6 (8.8)
Waist circumference ≤90 cm in men
SC 23 7 (30.4) 0.667
UC 30 7 (23.3)
Waist circumference ≤80cm in women
SC 32 3 (9.4) 0.657
UC 39 2 (5.1)
Systolic BP target: ≤135 mmHg SC 55 44 (80.0) c 0.001
UC 69 29 (42.0)
Diastolic BP target: ≤75 mmHg SC 55 15 (27.3) 0.577
UC 69 22 (31.9)
TG ≤ 1.7 mmol/L SC 45 32 (71.1) 0.080
UC 59 32 (54.2)
LDL ≤ 2.6 mmol/L SC 43 26 (60.5) c0.046
UC 57 23 (40.4)
HDL > 1.0 (male) SC 17 13 (76.5) 1.000
UC 22 17 (77.3)
HDL > 1.2 (female) SC 20 15 (75.0) 0.226
UC 28 15 (53.6)
bCVD risk (10 year risk < 10%) using lipid values
SC 42 17(40.5) -
bCVD risk (10 year risk < 10%) using BMI values
SC 55 5 (9.1) -
a p-value from Pearson chi-square test; b data could only be obtained for SC patients; cstatistically significant; BMI=body mass index; BP=blood pressure; CI=confidence interval; CVD=cardiovascular disease; HbA1c= Haemoglobin A1c; HDL=high density lipoprotein; LDL=Low density lipoprotein; SC=Simpler™ care; SD=standard deviation; TG=triglyceride; UC=usual care;
223
5.4.7.1 Lipid values at baseline and at 6 months
Findings in this section refers to Table 5.12. Both arms had improvements in TC, TG,
LDL and HDL at 6 months compared to baseline. However, these improvements were
not significantly different between arms. Of interest, there was significant reductions
(p=0.017) in the LDL level for the SC arm (baseline vs. 6 months) but this was not the
case for the UC arm.
There was a 5% increase in the number of statins prescribed at 6 months compared
to baseline for patients in the SC arm due to intervention recommendations by SC
pharmacists. However, this increase was not statistically significant. In contrast, the
UC patients had no change in the number of statins prescribed to them at 6 months.
5.4.7.2 Glycaemia control at baseline and outcomes at 6 months
The primary outcome measure, HbA1c were similar at baseline for both arms,
showing that the patients from the two arms were comparable at baseline. However,
there were significant decreases in HbA1c levels between the arms at 6 months
intervention (p<0.001). The patients in the SC arm who received care from
pharmacists using the Simpler™ tool showed average mean reductions in HbA1c of
1.59%, (p=0.001) at 6 months, whilst the UC arm differences was 0.25% (p=0.171) at
6 months compared to baseline levels. Figure 5.8 presents standard error for mean
HbA1c differences in both arms. Additionally, the standard error bars of each arm
did not overlap, meaning the Simpler™ intervention made a difference in the HbA1c
outcomes among patients in this research.
224
Figure 5.8: Standard error of mean HbA1c difference levels between baseline and 6
months for both arms
Of interest, the percentage of patients who obtained target HbA1c levels less than
7% (53mmol/mol) as set by the American Diabetes Association guidelines(16) were
greater 11/49 (22.4%) in the SC than the UC arm 4/65 (6.2%) at 6 months. These
differences were statistically significant (p=0.011). Similarly, in accordance with the
Malaysian diabetes guidelines (6), more participants 7/49 (14.3%) from the SC arm
achieved the target HbA1c of ≤6.5% (47.5mmol/mol) compared to the UC arm 1/65
(1.5%). Additionally, these differences were statistically significant (p=0.020)
between the arms (Table 5.13).
A majority of SC patients (57.1%) achieved a mean HbA1c reduction of 1% compared
to 28.6% of UC patients. This difference was found to be statistically significant
(p=0.002). Subgroup analysis found that patients of Melayu ethnicity, female
Stan
dar
d e
rro
r fo
r m
ean
Hb
A1
c (%
) d
iffe
ren
ce
Patient arms
225
patients and patients with mean baseline levels of more than 9% in the SC arm had
significantly improved HbA1c results compared to patients in UC arm as presented in
Table 5.14.
Table 5.14: Comparison of patients who achieved a mean reduction of 1% HbA1c
between arms
Variable No. patients (%) ap-value
Overall
SC (n=49) 28 (57.1%) b 0.002 UC (n=63) 18 (28.6%)
Patients of Melayu ethnicity
SC (n=40) 23 (57.5%) b 0.003 UC (n=49) 13 (26.5%)
Patients of non Melayu ethnicity
SC (n=9) 5 (55.6%) 0.349
UC (n=14) 5 (35.7%)
Female patients
SC (n=27) 16 (59.3%) b 0.006 UC (n=36) 9 (25.0%)
Male patients
SC (n=22) 12 (54.5%) 0.136
UC (n=27) 9 (33.3%)
Patients with mean baseline HbA1c≤9.0%/75 mmol/mol
SC (n=10) 5 (50%) 0.204
UC (n=14) 3 (21.4%)
Patients with mean baseline HbA1c>9.0%/75 mmol/mol
SC (n=39) 23 (59.0%) b0.008 UC (n=49) 15 (30.6%) a p-value from Pearson chi-square test; b statistically significant; SC= Simpler™ care; UC= usual care;
HbA1c= glycated haemoglobin
Comparison of FBG readings (baseline vs 6 months) showed significant improvement
for the SC arm, a reduction of 3.76 mmol/L (p<0.001) as shown in Table 5.15. In
comparison, FBG readings reduced by 0.63 mmol/L (p=0.524) in the UC arm. These
reductions were significantly different between arms (p<0.002). However, the FBG
results at six months were not significantly different between the arms. Figure 5.9
shows a graphical presentation of the changes in FBG values throughout the six
months. The different sizes of the box plots at each visit suggests different FBG values
226
during each patients’ visit. The shorter box plot at visit six compared to other visits
suggests that overall, SC patients had similar FBG values at this visit.
227
Table 5.15: Changes in blood glucose parameters at baseline and at 6 months follow
up in both arms
Arm n Baseline Median
(IQR)
6 months Median
(IQR)
Z stat
Baseline vs 6
months p-value
SC vs UC ap-value
(6 months)
SC vs UC ap-value
c(changes)
FBG SC 30 10.4 (4.0) 7.95 (3.45) -3.764
*b0.001 0.154 *0.002
UC 29 9.2 (2.0) 9.1 (3.70) -0.638
b0.524
RBG SC 9 12.45(0) 7.15 (0) -1.960
0.050 0.831 0.756
UC 9 11.6 (3.15) 9.1 (4.6) -1.475
0.140
PPG SC 2 12.1 (0) 11.0 (0) -1.342
0.180 -
UC 0 - - - - ap-value from Mann-Whitney U test for independent samples; bWilcoxon signed ranks test;
*statistically significant; cchanges refer to difference of 6 months values from baseline values; FBG=fasting blood glucose; PPG=post prandial glucose; RBG=random blood glucose
Figure 5.9: Median fasting blood glucose (FBG) in the SC arm during each visit to the
pharmacy
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5.4.7.3 Medication management
1) Patients’ medication adherence
Patients in the SC arm self-reported medication adherence using the 8-item MMMAS
score which revealed significant improvement, p<0.001 at 6 months (7.57, SD=1.12)
compared to baseline (5.86, SD=1.93). The number of patients who showed high
adherence (8-item MMMAS score =8) was 13 (23.6%, n=55) at baseline and increased
to 44 (80%, n=55) at 6 months. Figure 5.10 presents the mean adherence scores for
each visit in the SC arm. Table 5.16 reflects SC patients’ self-reported responses for
each of the 8-item MMMAS questions. Scores from all questions except one
(question no.5) showed significant differences pre-and post-intervention.
Figure 5.10: Changes in adherence scores in the SC arm according to 8-item
MMMAS tool
5.86
6.747.04
7.507.78 7.57
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6
229
Table 5.16: 8-item MMMAS responses at baseline and at 6 months in SC arm (n=55)
No. Questions Baseline 6 months’ intervention Baseline vs 6 months ap-value
Yes N (%)
No N (%)
Yes N (%)
No N (%)
1. Do you sometimes forget to take your pill? 33(60.0) 22(40.0) 5(9.1) 50(90.9) b <0.001
2. People sometimes miss taking medications for reasons other than forgetting. Thinking over the past two weeks, were there any days when you did not take your medicine?
17(30.9) 38(69.1) 5(9.1) 50(90.9) b 0.004
3. Have you ever cut back or stopped taking your medication without telling your doctor because you felt worse when you took it?
9(16.4) 46(83.6) 2(3.6) 53(96.4) b 0.027
4. When you travel, or leave home, do you sometimes forget to bring along your medications?
17(30.9) 38(69.1) 5(9.1) 50(90.9) b 0.004
5. Did you take your medicine yesterday? 49(89.1) 6(10.9) 53(93.4) 2(3.6) 0.145
6. When you feel like your disease is under control, do you sometimes stop taking your medicine?
8(14.5) 47(85.5) 1(1.8) 54(98.2) b 0.016
7. Taking medicine every day is a real inconvenience for some people. Do you ever get hassled about sticking to your treatment plan?
11(20.0) 44(80.0) 2(3.6) 53(96.4) b 0.008
8. How often do you have difficulty remembering to take all your medication?
Never/Rarely 24(43.6) 48(87.3) b <0.001
Once in while 11(20.0) 1(1.8)
Sometimes 13(23.6) 3(5.5)
Usually 6(10.9) 3(5.5)
All the time 1(1.8) 0 a p-value from independent t- test; b Statistically significant
230
Of interest, the questions that had the most improvement at 6 months compared to
baseline were question 1: pertaining to remembering to take medication, question 2:
reasons for forgetting to take medications other than the reasons stated in question
1, and question 4: on taking medications when travelling.
2) Medication-related problems
The MRPs identified for each SC patient during visits were recorded in the Simpler™
pro forma forms. The most common MRPs was patients’ non-adherence problems
which accounted for 135 of the 301 recordings (44.9%) of the total MRPs followed by
sub therapeutic dose (65/135, 21.6%) and needs additional therapy (52/135, 17.3%).
Table 5.17 presents the types of MRP identified and the causes of non-adherence.
The most frequent causes of non-adherence to medications was patients forgetting
to take their medicine (124, 68.1%) followed by patients preferring not to take their
medicine (42, 23.1%).
There were four recordings of adverse drug reactions, which were related to side
effects. Those were: 1) metformin (patient unable to tolerate the nausea and
vomiting), 2) vitamin B complex (caused drowsiness and vomiting), 3) perindopril
(caused dizziness), and 4) fluoxetine (caused insomnia). In all instances, pharmacists
communicated suggestions for alternative medications to doctors. In addition, SC
patients reported hypoglycaemia-like symptoms. There was a total of 23 episodes
among seven (12.7%) patients during the 6 months’ period. Pharmacists educated
patients on prevention and management of hypoglycaemia. Regrettably,
pharmacists were unable to assess the adverse drug reactions experienced by UC
patients.
231
Table 5.17: Number of medicine related problems identified by pharmacists for SC
arm over 6 months
Medicine related problems Frequency (%)
Unnecessary drug therapy 10 (3.3) Needs additional drug therapy 52 (17.3) Ineffective drug 29 (9.6) Sub therapeutic dose 65 (21.6) Adverse drug reaction 4 (1.3) Dosage too high 6 (2.0) Non-adherence 135 (44.9) Total 301 (100) Causes of non-adherence Frequency (%)
Does not understand instructions 14 (7.7)
Patient prefers not to take 42 (23.1)
Patient forgets to take 124(68.1)
Cannot swallow or administer drugs 2 (1.1)
Total 182 (100)
Out of the 301 MRPs recorded, pharmacists documented 111 (36.9%) interventions
made in collaboration with patients and doctors to resolve the MRPs as listed in Table
5.18. The interventions for non-adherence, focused on patient education and
counselling to improve medication adherence, is presented in Section 5.4.7.6.
232
Table 5.18: Number of pharmacist collaborations with SC patients and doctors
Collaboration with patient Frequency (%)
Reinitiated drug therapy in patients 21 (35.0)
Pill reminder chart or device for patients 39 (65.0)
Total 60 (100)
Collaboration with doctor Frequency (%)
Changed drug product 6 (11.8)
Discontinued drug therapy 5 (9.8)
Changed dosage 17 (33.3)
Not resolvable 0
Added additional medicine 23 (45.1)
Total 51(100)
The most common interventions provided by pharmacists to improve adherence
among SC patients were recommendations to buy a pill reminder device or providing
medication timing chart (39,65.0%) followed by reinitiating drug therapy based on
patient collaborations (21,35.0%). The most common suggestion accepted by
doctors and consequent therapy change was adding a medicine (23, 45.1%) out of
total doctor collaborations followed by a dosage change (17, 33.3%). Pharmacists’
recommendations to add medications included initiation of metformin, ACE-I/ARB,
statin and aspirin. However, there was a non-significant difference between the
number of patient prescribed medications at 6 months compared to baseline
between the two arms. Details of these differences are discussed in the following
sections. Pharmacists’ actions to resolve causes of non-adherence problems through
education and pharmacotherapy may have contributed to the increased number of
patients achieving high adherence score (8-item MMMAS=8) at 6 months compared
to baseline, approximately a three-fold increase.
233
5.4.7.4 Blood pressure (BP) control
There was a significant reduction in the systolic BP at 6 months compared to baseline
in the SC arm (p=0.005). In contrast, the UC arm showed an increase in systolic BP at
6 months compared to baseline. The difference in systolic BP at 6 months for the SC
arm was found to be significantly different from the UC arm. Although the diastolic
BP showed reduction in both SC and UC arms, the difference was not statistically
different between the arms (Table 5.12).
Figure 5.11 presents systolic BP and FBG values for the SC arm at each visit. Of
interest, there was a sharp decrease at visit 2, however the value increased at visits
3 and 4 before it decreased in visit 5 and remained at a similar value at visit 6. The
increase in systolic BP during visit 4 before decreasing at visit 5 was similar to FBG
values, which showed a similar trend.
Figure 5. 11: Comparison between mean FBG and mean systolic BP between each
visit
Further analysis found weak, positive association between FBG changes (visit 1 and
visit 6) and systolic BP changes (visit 1 and visit 6) for SC patients using the Spearman’s
122.00
124.00
126.00
128.00
130.00
132.00
134.00
136.00
138.00
0.00
2.00
4.00
6.00
8.00
10.00
12.00
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6
Syst
olic
blo
od
pre
ssu
re (
mm
Hg)
Fast
ing
blo
od
glu
cose
(m
mo
l/L)
SC patients' visit
Fasting blood glucose Systolic blood pressure
234
rank correlation. This association was statistically significant (rs=0.330, p=0.011). Of
interest, there was a similar weak but significant association between changes for
mean HbA1c and mean systolic BP changes pre-and post-intervention. (rs = 0.255,
p=0.007).
5.4.7.5 Lifestyle management
SC patients showed more reductions in BMI and waist circumference values
compared to UC patients, however, these improvements were not significantly
different between both arms at 6 months’ study. Of interest, time spent exercising
increased at 6 months (57.38 minutes; SD=77.34) compared to baseline (35.83
minutes; SD=56.51) among the SC arm and this increase was statistically significant.
(P=0.041).
Additionally, the number of SC patients who smoked at visit 1 (6/55; 10.9%) was
reduced to five patients by the end of visit 6 as one patient stopped smoking.
5.4.7.6 Education
All patients in the SC arm were given education on diabetes self-management during
each visit. The types of education given followed recommendations in the Simpler™
tool and are summarized in Table 5.19.
235
Table 5.19: Types of education provided to patients in the SC arm
Types of education Frequency (%) (n=55)
1. Management of hypoglycaemia
48 (87.3)
2 Self-monitoring of blood glucose
51 (92.7)
3 Reduce sodium intake
51 (92.7)
4 Management of stress and diabetes related distress
35 (63.6)
5 Foot care
47 (85.5)
6 Diet advice using plate model
51 (92.7)
7 Sleep hygiene
40 (72.7)
8 Knowledge and understanding of medicines
55 (100.0)
9 Medicine storage
52 (94.6)
10 Simple exercises
55 (100.0)
11 Use of Framingham risk calculator to educate patients
39 (70.9)
12 Medication optimisation during fasting month for Muslims and other religious arms
7 (12.7)
5.4.7.7 Cardiovascular risk reduction strategies
The cardiovascular risk scores for patients in the SC arm were calculated using two
calculators. One using the Framingham risk score (FRS) utilising patients’ lipid values
and the other using their BMI results. Patients in the SC arm had a statistically non-
significant reduction of CVD risk (1.05%) at 6 months compared to baseline: 21.96
(SD=14.27) vs 20.91 (SD=15.51)) using the FRS lipid calculator. There was a similar
non-significant reduction (2.91%) when using the FRS BMI calculator: 29.03
(SD=15.71) at baseline vs 26.12 (SD=14.68) at 6 months. Regrettably the FRS
calculation for the UC arm were not performed as some information required were
unable to be retrieved.
236
Interestingly, the SC arm had an increased number of total daily antiplatelet
medication prescribed for primary prevention to reduce CVD risk at the end of the
study in comparison to the UC arm and this difference was found to be significant,
p=0.016.
5.4.8 Comparison of QOL outcomes between the Simpler™ care and usual
care
The overall WHOQOL BREF score improved significantly (p=0.007) in both arms at 6
months. Note that a higher WHOQOL BREF score denotes higher QOL.(148) The
overall scores comprise of questions on self-evaluation of QOL and self-assessment
of health. The SC arm had significant improvements at all four domains at 6 months
compared to baseline: physical health (p=0.002), psychological (p=0.042), social
relationships (p=0.031) and environment (p=<0.001).
The two following domains were significantly improved in the SC arm with respect to
the UC arm at 6 months: physical health [14.68 (SD=2.31) vs 13.70 (SD=2.30);
p=0.021]; and environment [15.37(SD=2.16)] vs [14.53 (SD=2.05); p=0.030]. Physical
health incorporates activities of daily living, mobility and work capacity while
environment includes financial resources, home environment, health and social care
and opportunities for acquiring new information and skills. The remaining two
domains psychological (bodily image and appearance, self-esteem, spirituality,
negative and positive feelings, thinking, learning, memory and concentration) and
social relationship (personal relationships, social support, sexual activity) showed no
significant improvement between the arms. Table 5.20 compares the summary
statistics for the WHOQOL BREF scores converted to scores between 4-20 which is
comparable with the WHOQOL100.(11) Table 5.21 on the other hand shows the
scores that were converted to a 0-100 scale according to the WHOQOL-BREF manual.
237
Table 5.20: Changes in WHOQOL-BREF domain scores between both arms from baseline to 6 months follow-up
[scores transformed from 4-20 according to WHOQOL-BREF manual.(11)]
Domain Mean at Baseline (SD)
6 months mean (SD)
Mean difference (95% CI)
Baseline Vs 6 months
SC vs UC (Baseline)
SC vs UC (6 months)
ap-value bp- value bp-value
Overall
SC (n=55) 13.64(2.08) 15.38(2.31) 1.75 (0.97 to 2.52) *<0.001 0.730 *0.007
UC (n=67) 13.79(2.85) 14.09(2.73) 0.30 (-0.34 to 0.94) 0.353
Physical health
SC (n=55) 13.8061 (2.04) 14.68(2.31) 0.87 (0.33 to 1.42) *0.002 0.741 *0.021
UC (n=68) 13.9398 (2.37) 13.70 (2.30) 0.24(-0.68 to 0.20) 0.276
Psychological
SC (n=54) 14.4568 (1.62) 15.03(2.34) 0.62 (0.02 to 1.21) *0.042 0.354 0.147
UC (n=68) 14.1275 (2.28) 14.44 (2.14) 0.31 (-0.14 to 0.76) 0.177
Social relationships
SC (n=53) 14.6038 (2.03) 15.12(2.84) 0.74 (0.07 to 1.42) *0.031 0.500 0.169
UC (n=65) 14.2974 (2.74) 14.44(2.60) 0.30 (-0.28 to 0.88) 0.310
Environment
SC (n=55) 14.2961(1.51) 15.37(2.16) 1.07 (0.51 to 1.63) <0.001 0.770 *0.030
UC (n=68) 14.3897(2.03) 14.53(2.05) 0.14 (-0.25 to 0.53) 0.477 ap values from paired t-test; bp values from independent t-test; *statistically significant CI= confidence interval; n= sample size; SC= Simpler™ care; SD=standard deviation; UC= usual care
238
Table 5.21: Changes in WHOQOL-BREF domain scores between both arms from baseline to 6 months follow-up
[scores transformed from 0-100 according to WHOQOL-BREF manual.(11)]
Domain Mean at Baseline (SD)
6 months mean (SD)
Mean difference (95% CI) Baseline Vs 6 months
SC vs UC (Baseline)
SC vs UC (6 months)
ap-value bp- value bp-value
Self-evaluation of QOL
SC (n=55) 65.91(15.49) 74.09(17.32) 8.18 (2.21 to 14.15) *0.008 0.648 *0.020
UC (n=67) 64.55(16.94) 65.81(21.56) 1.12 (-4.74 to 6.98) 0.704
Self-assessment of health
SC (n=55) 54.55(19.89) 68.18(16.98) 13.64 (8.30 to 18.97) <0.001 0.379 *0.018
UC (n=68) 58.09(24.60) 60.66(17.45) 2.57 (-1.63 to 6.77) 0.226
Physical health
SC (n=55) 61.29(12.78) 66.74(14.44) 5.45 (2.04 to 8.87) *0.002 0.741 * 0.021
UC (n=68) 62.12(14.81) 60.61(14.38) -1.51 (-4.27 to 1.24) 0.276
Psychological
SC (n=54) 65.35(10.14) 69.21(14.63) 3.86 (0.14 to 7.57) *0.042 0.354 0.147
UC (n=68) 63.30(14.28) 65.25(13.38) 1.95 (-0.90 to 4.80) 0.177
Social relationships
SC (n=52) 66.27(12.79) 70.91(16.20) 4.65 (0.43 to 8.86) *0.031 0.500 0.169
UC (n=65) 64.36(17.15) 66.22(15.68) 1.86 (-1.77 to 5.49) 0.310
Environment
SC (n=55) 64.35(9.42) 71.04(13.48) 6.69 (3.19 to 10.18) *<0.001 0.770 * 0.030
UC (n=68) 64.94(12.70) 65.82(12.82) 0.88 (-1.57 to 3.33) 0.477 ap values from paired t-test; bp values from independent t-test; *statistically significant
239
5.4.8.1 Impact of patients’ characteristics on overall QOL score
The findings presented here refer to results presented in Table 5.22. Older patients,
aged more than the average age (56.6 years) in this study constituted 47.2% in the
SC arm and 71.6% in the UC arm. Interestingly older patients in both arms reported
better overall QOL than the younger patients. Similarly, SC patients reported better
QOL scores (15.46, SD=2.23) than patients in the UC arm (14.33, SD=2.38). This
difference was statistically significant (p=0.038).
The majority of patients in the SC (69%) and UC (70%) arms were using insulin. SC
patients who were using insulin reported lower QOL scores than SC patients without
insulin. Conversely, the QOL scores among patients in the UC arm were the same for
patients with or without insulin. In contrast, patients who were on OHA only,
reported better QOL in both arms compared to patients who were not prescribed
OHA. The QOL score difference was statistically significant (p=0.018) between arms.
Doctors’ visits consisted of usual patient monitoring which is conducted on average
four times yearly but less frequently if patients’ disease is well controlled and more
frequently if it is not. There was no significant difference in QOL scores between the
two arms for patients who had more than two doctors’ visits throughout the six
months’ duration.
Patients in the SC arm who had hypertension reported better QOL scores (15.42;
SD=2.35) than SC patients who did not have hypertension (15.00; SD= 2.10). In
addition, they scored significantly (p=0.009) better than the UC patients who had
hypertension (14.13, SD=2.68). The majority of patients in the SC (89.1%) and UC
(89.6%) arms had hypertension.
240
As expected, patients without nephropathy self-evaluated better QOL scores than
patients with nephropathy and the difference between SC (15.52, SD=2.23) and UC
arms (14.11, SD=2.73) was significantly different (p=0.005)
241
Table 5.22: Impact of patients’ characteristics on overall WHOQOL-BREF score
Patients’ characteristics
Overall score after 6 months (with characteristics and without characteristics)
SC vs UC p-value
Existing Mean (SD)
Non-existing Mean (SD)
Existing Mean (SD)
Non-existing Mean (SD)
Existing Non-existing
Sociodemographic +Age (≥56.6 year) 15.46(2.23) 15.31(2.41) 14.33(2.38) 13.60(3.41) *b0.038 b0.080
Family history of diabetes
15.31(2.29) 15.44(2.42) 15.33(2.22) 13.82(2.84) b0.836 *b0.030
Severity
Use of insulin 15.11(2.26) 16.00(2.35) 14.13(2.74) 14.10(2.72) a0.076 *b0.031
Use of OHA only 15.60(2.24) 14.40(2.46) 14.32(2.92) 13.56(2.01) *a0.018 b0.555
Resource utilization
Doctor visit ≥2times 15.37(2.33) 16.00(0) 14.43(2.80) 12.67(1.78) a0.058 b0.154
Comorbidity
Hypertension 15.42(2.35) 15.00(2.10) 14.13(2.68) 14.00(3.21) *a0.009 b0.414
Nephropathy 14.00(2.83) 15.52(2.23) 14.17(2.76) 14.11(2.73) b1.00 *a0.005
Number of medical conditions ≥2
15.00(2.63) 15.49(2.22) 14.60(2.91) 13.92(2.64) b0.774 *a0.003
OHA= oral hypoglycaemia agent; a p-value from independent t-test; b p-value form Mann Whitney-U test; *Statistically significant;+average age of cohort
Understandably, patients in the SC arm who had two or more medical conditions
reported lower overall QOL scores than patients who did not. Surprisingly, patients in
the UC arm who had two or more medical conditions reported better QOL scores.
However, this difference between SC and UC arms was not significant. Accordingly,
patients who had less than two medical conditions in the SC arm recorded significantly
better scores (15.49, SD=2.22) than UC patients (13.92, SD=2.64), p=0.003.
5.4.9 Analysis of patient case studies
Pharmacists’ application of the Simpler™ intervention tool improved patients’ clinical
and QOL outcomes. The following three patient case studies have been selected as they
showed the most improved HbA1c levels at six months compared to baseline. Details of
pharmacists’ interventions and comparisons of clinical parameters for each visit are
presented in Boxes 5.1 to 5.3 and in Figures 5.12 to 5.14.
1. Patient ID 417
Box 5.1: Case study for patient ID 417
Patient ID 417 was a 37-year-old man of Melayu ethnicity with a family history of
diabetes. His highest education level was secondary education and he worked as
security guard at a local school. He was diagnosed with T2DM in 2013. He
complained of chest pain during his first visit and was prescribed glyceryl trinitrate
tablets (GTN) and consequently sent for further medical examinations. His
medications before the intervention were statin, CCB, aspirin intermediate acting
insulin, metformin and sulphonylurea and neurobion. At visit six, GTN was added
to his list of medications.
243
Achieved HbA1c reduction of 8.8% (96.2mmol/mol) [from 16.8% (160.1mmol/mol)
to 8.0% (63.9mmol/mol)], LDL reduced from 2.80 mmol/l to 1.90 mmol/l and his
waist circumference reduced from 105cm to 90cm. His self-reported physical
exercise improved from none to 60 minutes per week and consequently his BMI
decreased from 33kg/m2 to 31kg/m2.
The pharmacist identified MRPs such as sub-therapeutic dosage and non-
medication adherence as reasons for therapeutic failure.
The reasons for non-adherence were ‘patient prefers not to take medication’ and
‘patient forgets to take’.
The patient developed fear towards insulin administration and was dependent on
his carer (mother) to administer it. Therefore he was unfamiliar with the insulin
administration technique. The pharmacist educated him on the correct technique
of administration and the beneficial effects of insulin.
Education was provided on weight loss; simple exercises; foot care; stress and
sleep hygiene; medicine storage; hypoglycaemia management; salt intake;
medication and smoking cessation.
The pharmacist provided him with a pill reminder chart and collaborated with the
doctor to titrate insulin and add aspirin as primary prevention to reduce CVD risk.
The patient scored social relationships the lowest (50.0) and physical domain (75.0)
the highest at pre-intervention, while at post-intervention he scored environment
domain the lowest (71.9) and physical domain the highest (85.7). The largest
improvement in his QOL assessment was social relationships (50 to 75).
There was a marked improvement in FBG and systolic BP when the patient’s medication
adherence score increased, as shown in Figure 5.13. This was expected as medication
adherence is associated with achieving therapeutic goals. This is further discussed in
section 5.5.1.3.
244
Figure 5.12: Comparison of 8-item MMMAS scores, blood glucose levels and systolic BP
at each visit for patient ID 417
1.2
5
6.5
4.5 6
.5 7.5
7.2
5
0
20
40
60
80
100
120
140
160
0
2
4
6
8
10
12
14
16
18
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6
Blo
od
pre
ssu
re m
m H
g
Blo
od
glu
cose
mm
ol/
L
8MMMAS FBG/RBG SBP
245
2. Patient ID 416
Box 5.2: Case study for patient ID 416
Patient ID 416 was a 56-year-old lady of Chinese descent with a family history of
diabetes. Her highest level of education was at primary level. She was married
and was taking care of her family and grandchild. She was first diagnosed with
diabetes and hypertension when she was 42 years old. She also suffered from
anxiety disorder. Similar to patient ID 417 above, her increased medication
adherence through the pharmacists’ input led to reduction in blood glucose and
systolic BP levels. Her HbA1c showed a reduction of 6.8% [from 13.20%
(120.8mmol/mol) to 6.40% (46.4mmol/mol)]. Her LDL reduced from 3.40 mmol/L
to 2.30 mmol/L, however her waist circumference and BMI did not show any
changes. Her self-reported physical exercise (walking, household chores)
improved from none to 30 minutes per week. Her medications before the
intervention were statin, CCB, aspirin, intermediate acting insulin, metformin and
sulphonylurea and calcium carbonate. At visit six, calcium carbonate was stopped,
however all other medications remained the same.
The major cause of her medication non-adherence was ‘forget to take and ‘prefers
not to take’ her medications including insulin particularly when travelling or staying
over at relative’s house.
The patient reported difficulty in sleeping from visits 1 to 3. The pharmacist’s
collaboration with the doctor resulted in discontinuation of her fluoxetine.
Consequently, there were no complaints of sleep by visit 4.
The pharmacist titrated insulin doses for optimum blood glucose levels.
Pharmacist education included sleep hygiene, hypoglycaemia management,
medication knowledge and storage, insulin injection technique and guidance on
self-monitoring of blood glucose.
She scored physical health (60.7) the lowest and social relationship the highest
(66.7) pre-intervention. At post-intervention, she scored physical health (64.3) the
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lowest and psychological domain the highest (70.8). Psychological domain (62.5 to
70.8) scores showed most improvement in her QOL assessment pre-and post-
intervention.
A comparison of systolic BP, blood glucose and medication adherence score is shown in
Figure 5.14
Figure 5.13: Comparison of 8-item MMMAS scores, blood glucose levels and systolic BP
at each visit for patient ID 416
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3. Patient ID 508
Box 5.3: Case study for patient ID 508
Patient ID 508 was a 68-year-old man of Melayu ethnicity who also had
hypertension. He lived with his wife on a small landholder (palm oil plantation)
that he owned. His highest level of education was at primary level. His HbA1c
results reduced by 6.2% (67.7mmol/mol) [from 15.10% (141.5mmol/mol) to 8.90%
(73.8mmol/mol)]. His lipid value, waist circumference and BMI did not change.
However, his physical activity improved from 60 to 105 minutes per week. His
medications before the intervention were statin, CCB, ACEI, beta blocker,
frusemide, metformin and gliclazide. At visit six, premix insulin was added and
gliclazide was stopped.
Ineffective medication and patient non-adherence to medication were identified
as reasons for not achieving therapeutic targets.
The pharmacist also identified the need for insulin as patient’s did not achieve
glycaemia targets with his current OHA (metformin and sulphonlyurea)
Pharmacist also recommended aspirin to be added due to increasing FRS (lipid =
31.80, BMI =51.40) at visit 1. Furthermore, he was more than 65 years old as
required by the 2015 Malaysian diabetes guideline. However, the pharmacist
suggestion was not accepted as the doctor was concerned of increased bleeding
caused by aspirin in his age group.
There was a need to simplify his medication regime to a fixed-dose combination to
increase medication adherence and the pharmacist suggested telmisartan +
amlodipine. The doctor decided on perindopril + indapamide.
The reasons for non-adherence were ‘patient prefers not to take’ and ‘patient
forgets to take’. The patient misunderstood dosage instructions: he took one
tablet of perindopril + indapamide twice daily instead of two tablets once daily as
instructed. This was rectified at visit 5.
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The pharmacist collaborated with the doctor to initiate insulin at visit 3 which the
patient refused at visits 1 and 2.
Patient education was provided on insulin, salt intake, medication adherence, diet,
foot care, sleep hygiene, simple exercise, hypoglycaemia management, medication
knowledge and storage and dose administration time. He scored psychological
domain the lowest (62.5) and scored high marks on both social relationships and
environment domains (75.0) equally. At post intervention, he scored psychological
domain the lowest (50.0) and environment domain the highest (75.0). The physical
health domain showed the largest improvement pre-and post-intervention (64.3
to 70.8).
In contrast to the previous two patients mentioned above, patient ID 508 did not achieve
therapy outcomes even though he achieved the highest score for medication adherence
from visits 1 to 5 as shown in Figure 5.15. This was because the doses prescribed for his
antihypertensive and OHA medications were not the optimum doses to achieve required
outcomes. However, his glycaemic and BP improved at the final visit after pharmacist
educated him on the correct dosage instructions at visit 5.
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Figure 5.14: Comparison of 8-item MMMAS scores, blood glucose levels and systolic BP
at each visit for patient ID 508
5.5 Discussion
The Simpler™ intervention tool was successfully implemented in seven primary health
care clinics in six districts in the state of Johor, Malaysia. A RCT was chosen as the
methodology to assess the impact of the use of the tool as it reduces selection and
confounding biases. Thus it provided the most reliable evidence in terms of measuring
effectiveness of healthcare interventions.(3)
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5.5.1 Patients’ clinical outcomes based on the Simpler™ tool indicators
In Phase Three research the pharmacists in the intervention arm used the Simpler ™ tool
in the management of patients with T2DM. At baseline, patient in both arms were
similar in clinical and QOL assessments. However, at 6 months, the clinical outcomes of
the intervention patients showed positive results through a significant decrease in the
HbA1c levels and systolic BP compared to control arm. In addition, the Simpler™
intervention also improved other clinical outcomes such as FBG, LDL and HDL levels at 6
months compared to baseline. The intervention also led to increases in prescribed
statins and a significant increase in daily antiplatelet use as well as significant
improvements in QOL assessments between arms.
The magnitude of HbA1c improvements pre-and post-intervention measured by Cohen’s
d and Hedges’g between both arms were comparable to most RCTs performed among
hospital outpatients in Malaysia.(158, 159) Patients in the intervention arm also self-
reported significantly better QOL outcomes than the control patients in the physical and
environment domain of the WHOQOL-BREF questionnaire. Specifically, older patients,
without a family history of diabetes, on OHA, with hypertension, without nephropathy
and having two or less medical comorbidities self-evaluated better QOL scores.
In this phase, there were 27/61 (44.3%) SC patients who missed their appointments and
thus did not complete the required six visits to the pharmacy as per protocol. However,
the research team agreed to include patients who attended a follow up meeting with the
pharmacist at least three times during the six months research period for data analysis.
This is consistent with previous studies which found that patients showed a significance
difference in their clinical outcomes at three months of follow up. (123, 158)
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5.5.1.1 Cholesterol control
The intervention arm showed significant improvements in LDL and HDL at six months
compared to baseline (baseline LDL: 3.09 mmol/L; baseline HDL: 1.28 mmol/L). The
improvement in LDL is consistent with previous RCT diabetes intervention and
retrospective studies conducted by pharmacists in hospital settings in Malaysia (161,
327) and Hong Kong (130). Their baseline values ranged from 2.11 to 3.22 mmol/L. A
RCT conducted in one community pharmacy in Brazil also had similar improvements in
LDL and HDL levels as this research from baseline value: LDL (3.18mmol/L) and HDL
(baseline value: 1.38mmol/L).(136) Similar to this research, the higher baseline levels in
the aforementioned studies enabled higher potential for decreases in cholesterol levels.
Although the improvements in LDL values were not significant between arms, the
proportion of patients in the intervention arm who achieved the LDL target set by the
Malaysian diabetes guidelines was significantly more than the patients in the control
arm. Additionally, more patients in the intervention arm achieved the HDL target level
compared to the control arm. Both improvements in LDL and HDL can be associated with
the increase in prescribed statins which is able to induce an increase in HDL and decrease
in LDL .(343) In addition, the increase in exercise and diet changes recommended by
pharmacists could have contributed to the improvements.
5.5.1.2 Glycaemia control
The overall decrease of HbA1c levels for the intervention arm patients in this research
was consistent with the findings from RCT studies conducted in community and hospital
settings in Malaysia (128, 158, 159) and in other parts of the world.(13, 14)
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The results from the UKPDS trial (326) were used to estimate the effectiveness of the
Simpler™ intervention tool on blood glucose control. The UKPDS trial found a 1% change
in HbA1c before and after intervention was associated with a 14% reduction risk for
myocardial infarction, 37% for microvascular complications and 21% for deaths related
to diabetes. The method of using HbA1c levels to measure the effectiveness of an
intervention has been used by previous studies.(13, 14, 135) In this research,
pharmacists utilising the Simpler™ tool reduced the patients’ mean HbA1C by more than
1%.
The proportion of patients who achieved a 1% reduction pre-and post the study in HbA1c
was significantly more in the intervention arm compared to the control arm. The number
of patients with baseline HbA1c > 9% (74.9 mmol/mol) that achieved a mean reduction
of 1% in the intervention arm was significantly more compared to patients with baseline
values of <9% (74.9 mmol/mol). This results are similar to findings from a systematic
review on diabetes interventions conducted internationally that showed a greater
reduction in HbA1c with higher baseline levels [more than 9% (74.9 mmol/mol)].(13)
Nevertheless, the intervention pharmacists managed to improve HbA1c values in these
patients who represented the majority (71.0%) of patients in our baseline population.
Even though, this research was not statistically powered initially to account for
differences among different ethnicities and gender, significantly more patients in the
intervention arm from Melayu ethnicity and female gender achieved a mean reduction
of 1% for HbA1c. The FBG readings between both arms did not significantly differ at six
months. This could be because only small numbers of patients from both arms were
being measured for FBG. There were other contributing factors that could affect the
results such as medications taken, posture, current illness, stress and time FBG was
taken, for instance in the morning or afternoon as suggested by a review study.(344)
However, the magnitude of change at six months from baseline for the intervention arm
253
were significantly different when compared with changes in the control arm. This further
suggests the impact of Simpler™ interventions on glycaemic improvement.
The variation in FBG levels among intervention patients during each visit was found to
be associated with systolic BP values. This is consistent with findings from a recent cross
sectional study on 2092 elderly Chinese patients conducted in China that reported
increased FBG was associated with high systolic BP values.(345) In addition, previous
epidemiological research has documented increased hypertension among patients.(346)
Of interest, most patients (110, 88.7%) from both the intervention and control arms had
hypertension.
Pharmacists were not able to confirm whether the hypoglycaemia like symptoms
encountered by patients (12.2%) in this study were true hypoglycaemia. However, the
proportion of patients in this study who reported similar hypoglycaemia symptoms were
less than a before-after diabetes intervention study conducted for six months, during
which 58.1% of patients reported hypoglycaemia like symptoms.(133)
5.5.1.3 Medication management
Reasons for increased medication adherence were probably due to increased patient
education on knowledge and understanding of medication as well as self-management
skills, discussed in Section 5.5.1.6. This finding is consistent with two recent studies
conducted in Malaysia and with another study conducted in Hong Kong.(86, 130, 347) In
this study, the main causes of self-reported non-adherence was ‘patient forgets to take’
(68.1%). Most patients were on a minimum of four different medications namely
metformin, ACEI, CCB and simvastatin. Twelve (21.8%) patients had more than two
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comorbidities which further increased their medication regimen complexity and the
importance of being adherent. Indeed, a recent review identified medication regimen
complexity being related to medication non-adherence.(348)
In this study ‘sub therapeutic dose’ and ‘needs additional drug therapy’ was the most
frequent MRPs encountered and consequently was solved by pharmacists’
recommendations to prescriber and titrating the doses in the case of insulin.
Pharmacists collaborated with doctors to initiate medications such as ACEI, insulin,
metformin and statins. This is similar to a retrospective study that involved multiple KKs
conducted in Malaysia where half of pharmacists’ interventions involved dosage
adjustment and the remainder were changes to OHA, cholesterol and antihypertensive
medications.(160) In addition, pharmacists’ efforts in identifying other MRPs such as
adverse drug reactions, ineffective drugs and high medication doses and solving these
issues could have increased adherence levels. A large RCT study conducted in the USA
supports this view.(62)
Previous studies conducted in hospital settings in Malaysia as well as other countries
have also shown that pharmacists’ recommendations resulted in positive outcomes and
were favourably accepted by doctors.(64, 120, 125) Nevertheless, in this study setting,
the fact that pharmacists and doctors were in close proximity enabled effective
communication. However in settings where community pharmacies are not located in
the same premise as the GP clinic/practice, there is often a time difference between
identification of medication problems and subsequent correspondence with GPs which
can impact on outcomes.(64)
Additionally, the pharmacists had autonomy to titrate insulin doses up to two units at
each time as part of an agreed collaboration with the doctors. This avoided a time lag
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between pharmacists’ recommendations and communication with the prescriber during
follow-up visits when patients did not have a doctor’s appointment. Published meta-
regression analysis found independent insulin titration by pharmacists resulted in
improvement in HbA1c if patients’ mean baseline was more than 9%
(74.9mmol/mol).(13) In this research, Phase Three participants’ average HbA1c for both
control and intervention arms were 10.65% (92.9mmol/mol) and similar to the study,
the intervention arm reported greater reduction of mean HbA1c compared to the usual
care patients.
5.5.1.4 Blood pressure control
In this study, systolic but not diastolic BP significantly reduced in the intervention arm at
six months compared to baseline and between arms. This is similar to a recent RCT study
conducted in a hospital setting in Malaysia (161). However, other studies conducted in
KK settings or other hospitals in Malaysia have not achieved significant improvements in
either systolic or diastolic BP.(64, 86, 158-160) This BP improvement is also consistent
with RCTs conducted among multiple primary health care centres in Brazil, Canada the
UK, (136, 349, 350) but not achieved in other similar settings in Pakistan and
Australia.(122, 140)
The significant decrease in systolic BP is associated with a 50% reduction in stroke or
myocardial infarctions and was equally as important as glycaemia control in the UKPDS
trial.(26) There are numerous published studies on the association of high salt intake
and hypertension.(351) Pharmacists in the intervention arm actively educated patients
on the importance of reduction of salt intake as recommended by the 2015 Malaysian
diabetes guidelines.(6) Furthermore, this is consistent with the findings from the TONE
trial (trial of non-pharmacological intervention in the elderly) among 875 men in the USA.
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The trial found reduced salt intake in the elderly (60-80 years of age) led to a decrease in
BP and reduction in the need for antihypertensive medications.(352) This could explain
a higher proportion of patients in the intervention arm achieving systolic BP targets
compared to the control arm.
The average BMI for both intervention and control arms at baseline were 29kg/m2. This
is classified as obese (BMI≥23kg/m2) in Malaysia. A study conducted among 399 patients
in China found that patients’ BMI and waist circumference were associated with their
BP. This study found obese patients tend to have increased salt intake and consequently
had higher BP compared to patients with low salt intake.(353)
With regards to diastolic BP targets, slightly more patients in the control arm than the
intervention arm achieved the target BP. This could be contributed to patients’ age
factor. Systolic BP has been shown to rise between the ages 30 and 84 and over, the
diastolic BP tends to decrease from the age of 60 to 84 onwards according to a recent
study conducted in the UK.(354) The average age of patients in the intervention arm was
55 years while the average age for the control arm was 58 years which was closer to the
age range mentioned above for diastolic BP decrease. However findings from the MRFIT
trial showed greater CVD risk with each increment of systolic BP increase and individuals
with increased systolic and not diastolic BP were at greater risk of stroke(355) and
mortality(356).
The reduction of BP in visit 2 and gradual increase to visit 4 before achieving a constant
level in visit 5 and visit 6 could be explained by patients’ follow up visits with pharmacists
which coincided with doctors’ appointments. Therefore, systolic BP increase in these
visits could be the ‘white coat effect,’ documented in previous studies.(357)
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5.5.1.5 Lifestyle management
The non-significant reductions in BMI and waist circumference among intervention
patients compared to the control arm at six months is consistent with several published
RCTs conducted in Malaysia, the UK, the USA, Hong Kong, Iran, Jordan, Australia and
Brazil.(64, 123-125, 127, 130, 134, 136)
Although pharmacists actively educated SC patients on diet and exercise the intervention
did not match the intensive approach adopted in the Look AHEAD study which was
conducted in the USA from 2001 to 2012.(358) The 5145 participants in the Look AHEAD
study were provided meal replacements with liquid shakes and meal bars and were
instructed to achieve exercise target ≥ 175min/week by month six of the study. They
participated in counselling as well as individualised interventions twice monthly.
Consequently, there were significant improvement in weight loss and physical exercise
in the intervention patients compared to the control. Conversely, a systematic review
on the impact of improved diet and increased exercise found significant reductions in
BMI and waist circumference if education and motivation were given at the early phase
of newly diagnosed patients with diabetes.(359)
These studies highlight the need for a comprehensive approach and ideally pharmacists’
diet advice needs to be coupled with frequent monitoring and possibly nutritional
supplements although this may not be feasible in daily practice due to time and funding
constraints. Alternatively, paid nutritional services which deliver nutritionally balanced
meals and slimming centres which focus on weight loss technology may facilitate
patients achieve their BMI and waist circumference targets. However, the costs of using
these services may pose a barrier to some patients. Nevertheless, this research showed
non-significantly reduced BMI and waist circumference averages in the SC arm of 0.35%
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and 1.54%. In contrast, the control patients had non-significantly increased BMI of 0.68%
but reduced waist circumference by 0.06%. Previous studies have reported that uptake
of physical exercise may be difficult among older and obese patients which constitutes
majority of Phase Three research population.(360) Another reason may be that exercise
in hot and humid conditions can exert physiological strain as shown in a previous
study.(361) Therefore, exercise may be more difficult to implement in a tropical climates
where patients have little air conditioning and no access to air conditioned gymnasiums.
However, a study on follow-up of unsupervised gymnasium-based home exercise,
following a 12 weeks supervised exercise training improved exercise tolerance among
T2DM patients.(362) This findings might help patients implement an active lifestyle.
5.5.1.6 Patient education
The intervention patients were given education on diabetes self-management and on
medication knowledge during their multiple visits to the pharmacist. This may have
improved their adherence to medication and application of the lifestyle indicators. The
findings from this RCT is comparable to other RCTs conducted in Malaysia that
incorporated patient education in their methodology.(86, 160, 161)
In this study, education given by pharmacists was culturally and religiously sensitive for
patients from different ethnicity and customs. Each of the pharmacists could speak two
to four different languages which further enhanced the patient pharmacist relationship.
This is consistent with similar studies worldwide regarding culturally sensitive
educational programs.(96, 252)
A low number of patients were given education on medication consumption during
fasting (indicator for education factor in the Simpler™ tool) for religious (Muslim) groups.
This was because only one patient practiced fasting during the research period. The
fasting month for Muslim patients ran from 6th June to 5th July 2017. Phase Three
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recruitment started during the second week of June and the majority of patients were
recruited by pharmacists during the second week of July. This explains the reason why
only one patient was recorded to receive education on this indicator.
Pharmacists’ education on the beneficial effects of insulin in glycaemia control
contributed to overall improvement in HbA1c levels. This is mainly because some
patients in this study ‘preferred not to take’ insulin as they had negative associations
with insulin. This is consistent with two Malaysian qualitative studies which found lack
of knowledge related to diabetes and constraints in patients’ ability to control diabetes
the biggest barrier in achieving therapeutic targets.(71, 363) .
5.5.1.7 Cardiovascular risk reduction strategies
Despite reductions in BP and LDL levels, both of which are factors incorporated in the
FRS calculation, the overall FRS reductions were not significant at six months from
baseline. This could be due to the age factor as the risk of having CVD increases with
age. In this research the average age for the SC arm was 55 years. Despite this, the CVD
risk factor reduction of 1.05% using lipid results was consistent with two RCTs conducted
in Australia and Hong Kong which achieved 1% and 1.64% respectively.(130, 364) Similar
to this RCT, the intervention patients in both studies mentioned had increased
antiplatelet medications prescribed at the end of study compared to the control patients.
5.5.2 Quality of life outcomes
Baseline QOL scores were statistically similar among both arms, suggesting that the
baseline characteristics were homogenous. However, at six months, all single domains
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improved significantly in the intervention arm compared to baseline values. This was
not the case for the control arm. The improvement in the single domains reflects
patients’ management of their daily tasks and could possibly be attributed to compliance
to pharmacists’ lifestyle advice as also suggested in a similar RCT.(137) The two domains
that showed significantly improved scores at six months comparing the intervention arm
with the control arm were physical health and environment. Our study is also compatible
with QOL results from a specific educational intervention conducted among patients in
a diabetes clinic in Iran. Similar to our results, there were significant improvements in
self-evaluation of QOL, self-assessment of health and the physical health domain
comparing the intervention arm with the control arm.(365)
Our research findings are also consistent with pharmacist led diabetes intervention
studies conducted in hospitals in Nigeria and in India.(137, 366) The results from this
study are also consistent with a study conducted among outpatients in a medical centre
in Malaysia.(158) Although a different QOL instrument was used (EQ-5D-3L), the
significant improvement in mobility corresponds to the physical health domain in
WHOQOL-BREF used in our study. However, the medical centre study also showed
significant improvement in anxiety levels among the intervention arm versus control arm
which our study did not demonstrate (psychological domain).
The psychological domain in this research did not show significant improvement
between arms. One reason could be attributed to the non-significant reduction in weight
loss (BMI) for both arms which is associated with body image. This view is consistent
with a systematic review conducted on 36 studies which found improved body image
was associated with weight loss.(367) Body image is a facet relating to the psychological
domain of the WHOQOL-BREF questionnaire. In addition, previous studies have found
that weight loss led to improved mood and self-confidence.(368, 369)
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Likewise, there were no significant improvement between groups for the social
relationships domain. However, this domain was ranked the highest at baseline and at
6 months compared to the other three domains for both arms in this research. Similar
high scores were found in a 2015 cross sectional study conducted among T2DM patients
from primary healthcare clinics in Malaysia (370) and in a 2016 study in Iran.(371)
Correspondingly, the high social relationship domain scores could be attributed to the
existing strong social support through individual, community and healthcare in Malaysia
as reported in a Malaysian study conducted among 175 patients in a primary care
centre.(372) Social support was considered important as it decreases diabetes distress
and subsequently lead to improved outcome as documented in a systematic review on
30 studies.(373) Nevertheless, in contrast to the UC patients, the SC patients had
significant improvement pre-and post-intervention for this domain.
5.5.2.1 Impact of patients’ characteristics on QOL outcomes
In a systematic review study on QOL assessment among patients with diabetes found
that younger patients may benefit more from pharmacists intervention.(13). In contrast,
this research helped older patients improve their glycaemic control and reported
improved QOL scores.
The use of insulin in our study was associated with negative impact on QOL compared
with the use of an OHA. This was consistent with a recent audit of patients with diabetes
from major ethnic arms in Malaysia and in Taiwan.(19, 146) The audit found that insulin
usage necessitated patients to adhere to additional requirements such as daily self-
monitoring of blood glucose and diet restrictions. The additional restrictions could have
caused the patients to rate their QOL scores lower. Similar to the Taiwan national health
management system(19), the Malaysian public health care system(319) subsidises
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patients for consultations with healthcare professionals and for medications, however
needle costs for insulin administration and blood glucose monitoring costs are not
covered. Possible collaboration with insurance schemes and medical companies would
be ideal to support these additional costs.
The majority of patients in both arms diagnosed with hypertension and on
antihypertensive medications reported better QOL than patients who did not have
hypertension. This finding is consistent with a study conducted in Brazil where
improvements in physical health scores and medication adherence were reported after
educational interventions among this patient group.(374)
The lower QOL score among patients with multiple comorbidities in the intervention arm
is similar to several studies conducted in Malaysia and elsewhere (137, 370, 375)
highlighting that patients with illnesses in addition to diabetes have a significant health
burden.
5.5.3 Strengths of Phase Three study
The Phase Three study had a number of strengths which were different from previous
documented intervention studies. All Simpler™ trained pharmacists were from the
community setting, previously not formally trained in diabetes management and had less
than three years’ experience of providing diabetes management services. Yet, the
overall HbA1c improvement was comparable to that of RCTs employing pharmacists who
have more than three years of clinical experience and who are trained to provide services
in the hospital setting.(122, 124, 130)
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This study demonstrated that pharmacists with limited clinical experience but with
adequate support through the Simpler™ intervention tool effectively improved clinical
and QOL outcomes of patients in primary healthcare clinics in Malaysia. This suggests
that the Simpler™ tool can be utilised by a greater pool of pharmacists. Overall, the
findings from this study may be generalizable to pharmacists working in any community
setting providing diabetes management services; have access to patients’ medical
records; in countries with similar diabetes guidelines; and applies similar inclusion and
exclusion criteria as this research. This study however was done in an environment of
close contact with prescribers.
Since the Simpler™ tool was a multifactorial structured intervention, it was difficult to
isolate a single contributing factor. Therefore, it was highly probable that the
combination of improved glycaemic, cholesterol and blood pressure levels, increased
medication adherence and the slight increase in physical activity may have contributed
to patients’ improvement as was postulated in a previous RCT study conducted in
Australia.(140) Furthermore, several studies have found that multifactorial
interventions resulted in greater improvements in clinical outcomes compared to a
single intervention.(94, 95)
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5.5.4 Limitations
This RCT also had limitations. First, the RCT was conducted in seven clinics encompassing
six districts in the state of Johor and some variation could have occurred with
pharmacists’ relationships with doctors.
Second, there were problems obtaining baseline clinical values such as HbA1c, lipid and
creatinine results from both arms. Hence the values obtained ranged from the previous
month to previous four months. However, every effort was made to obtain the most
recent results before the trial commenced and on completion for both arms.
Third, as both intervention and control patients were recruited from the same primary
care health centre, contamination in the control arm was likely. While patients were
unaware to receiving the intervention or the usual care, pharmacists, nurses and doctors
knew which patients were in the intervention or usual care arms. This could have
influenced the type of care the patients in each arm received. This is because it was
possible that the same doctors were involved in treating intervention as well as control
patients and could have applied pharmacists’ recommendations for intervention
patients to control arm patients. Nevertheless, the effect of any contamination did not
impact the improvements seen in the intervention arm.
Fourthly, the Hawthorne effect (awareness of research participation) in this RCT may
only be partially neutralised.(376) This is because although both arms were given
appointments by the pharmacists and were aware of their participation in this research,
some of the effect may still exist in the intervention arm as they had more visits to the
pharmacist than the patients in the control arm. Therefore, increased contact time with
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pharmacists may have influenced patients’ compliance towards their treatment as
shown in several diabetes intervention studies.(377, 378) Nevertheless, patients in the
control arm also made frequent visits to dispensing pharmacists who equally provided
counselling and advice on medications and lifestyle modifications although not as
intensive and extended as the intervention pharmacists.
In this research, pharmacists were required to follow up the patient every month for six
months. However, it showed to be a difficult process as over half of the patients
recruited missed appointments or visited the pharmacy when pharmacists were busy
with dispensing tasks. Therefore only 34 (44.2%) out of 77 patients recruited managed
to complete all six visits. Pharmacists’ efforts to remind patients of their appointments
placed extra burden on their increasing workload. Thus, future research should focus on
optimum face to face or telephone interventions intervals between patient and
pharmacists to improve diabetes end points while still allowing room for self-care
management.
Certain information for both intervention arms and the control arm were missing for
some patients during the research period. Accordingly, pharmacists were contacted to
retrieve a majority of the missing data. Other times, pharmacists had to contact patients
to retrieve information such as education and occupational background. Regardless,
some data such as HbA1c results and lipid results from both arms could not be obtained.
Some patients had taken their meals prior to the finger pricking tests. Subsequently their
finger pricking test result was therefore categorised as random blood glucose (RBG)
which reduced the number of patient with FBG results. As the average age of patients
in the SC arm of Phase Three research was 55 years, there is a need to evaluate the
compliance level in younger age group patients. Finally, some recommendations by
pharmacists such as addition of antihypertensive therapy were only implemented close
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to the end of the study period, hence the beneficial effects may not have shown until
after the trial period ended.
5.6 Conclusions
The aim of the present phase was to determine the impact of utilising all seven diabetes
indicators in improving patients’ clinical as well as QOL outcomes. This study has shown
the benefits of pharmacists utilising a structured and consistent diabetes tool, the
Simpler™ tool, to make individualised, evidence-based interventions in the clinical
management of T2DM. Most notably were the improvements in glycaemia, blood
pressure and medication adherence results in addition to QOL outcomes. This study
contributes to the body of evidence that suggests the need for multifactorial
interventions which includes all seven diabetes factors to reduce diabetes related
complications. The results indicate that pharmacists in community or hospital settings
with or without prior formal diabetes training can be trained to use an appropriate tool,
such as the Simpler™ tool, to deliver quality diabetes care.
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6.1 General discussion
The prevalence of diabetes is increasing worldwide, and particularly in Malaysia.(21) Of
significance is the number of diabetes related complications which are also on an
increasing trend.(23) Diabetes management is complex and requires multifactorial care
to reduce the risk of complications. The multifactorial intervention, the Simpler™ tool
consisted of seven essential factors as outlined in diabetes guidelines.(6, 7, 16, 17) These
are cholesterol, glucose, blood pressure control, medication, lifestyle and CVD risk
management, as well as provision of education. The need for a multifactorial
intervention was exemplified in several landmark trial studies, namely the UKPDS,
ADVANCE and ACCORD studies (26, 27, 30) which successfully reduced the rates of
premature morbidity and mortality associated with T2DM. To the best of our
knowledge, the role of a structured multifactorial diabetes intervention tool which
incorporates all seven evidence-based diabetes management factors has not been
evaluated.
Many studies have documented the beneficial outcomes due to pharmacists’ provision
of care in collaboration with other healthcare professionals.(13, 14) Yet, other studies
have identified pharmacists’ insufficient knowledge and skills as barriers to provide
medication management services.(135, 264) Thus, some diabetes intervention studies
conducted by pharmacists (379) have not achieved a 1% reduction or greater for HbA1c
which is the required percentage to reduce CVD and mortality risk recommended in the
UKPDS trial.(326) There are two postulations for these varied patient outcomes. Firstly,
it is not clear if all the guideline required diabetes factors mentioned above were
necessarily addressed in these studies. Secondly, there were variations in pharmacists’
skills and experience during the medication review process. To be able to provide quality
diabetes care, knowledge and skills on pharmaceutical issues such as MRPs, dosage
adjustments and modification of medications are important. As most of these studies
269
were conducted by pharmacists with extensive clinical experience, it remained unknown
if similar outcomes could be achieved in community practice settings by pharmacists
with limited clinical experience. Accreditation programs for pharmacists wishing to
specialise in diabetes care such as to become a credentialed diabetes pharmacist exist in
Malaysia and Australia. However, a relatively small number of pharmacists undergo this
training and pharmacists are not required to be credentialed to provide diabetes
management services. Both postulations were supported by findings from systematic
reviews.(13, 380)
The overall aim of this research was to: 1) develop and validate a structured pharmacist
type 2 diabetes (T2DM) intervention tool, referred to as the Simpler™ tool; 2) explore
the impact of targeted training addressing pharmacists’ knowledge and ability to deliver
evidence-based diabetes care and; 3) determine the effectiveness of a multifactorial
evidence-based diabetes intervention tool among T2DM patients. To achieve the overall
aim, it was essential systematically to develop and evaluate the intervention tool
through Phases One and Two. Since this research was exploratory in conception, the
outcomes of each phase informed the development of the next phase. It was deemed
important to collectively apply all factors and indicators required in diabetes
management guidelines and obtain consensus on the content, format and design of the
tool. An acronym was obtained through rearranging the first or second alphabet letter
from the words in the seven diabetes management factors. The seven factors and
indicators were then developed into the acronym Simpler™ whereby each letter of the
word represented each of the seven diabetes factors. The notion to use an acronym that
represents each required intervention was based on tools such as the SOAP note (an
acronym for subjective, objective, assessment, and plan) which followed a similar
technique.(187, 189, 190, 237) SOAP is used widely by healthcare professionals to
document patients’ assessment and care plans.
270
The Simpler™ tool, allows users to retrieve and organize information and use their
judgement based on that information to make an intervention if necessary, as
recommended by Weed.(177) The Simpler™ tool is grouped according to each outcome
such as glycaemia, cholesterol, BP and medication adherence. Once the acronym,
Simpler™ was developed, the indicators corresponding to the factors were listed. The
decision on the list of indicators to be included and the order it should appear was
achieved through Phase One during which 12 diabetes experts from Australia and
Malaysia reached consensus using the Delphi method. The Delphi method explored
disagreements and attained consensus among the panellists(200, 213) and has been
used in similar studies on tool validation in healthcare.(179, 202-209, 212) This
methodology was selected as it enabled respondents to consider their answers and to
subsequently amend their initial decisions.
Phase Two aimed to explored pharmacists’ perceptions of the tool’s relevance and
usefulness to deliver quality diabetes care in daily practice settings. To achieve this, a
training program incorporating the application of the Simpler™ tool was developed.
Phase Two methodology followed the format of previous studies which had explored
pharmacists’ views during application of new skills and knowledge on completion of
training programs.(381, 382) Participants recruited were pharmacists from community
settings without any formal diabetes training. Upon using the tool in practice for a
month, pharmacists’ interviews revealed the Simpler™ tool to be beneficial and
functional when conducting diabetes MMS. Overall participants from both countries
agreed that the Simpler™ tool was structured, comprehensive, evidence-based and user
friendly. The most obvious finding was the need for participants to be pre-trained for
effective use of the tool and the need to supplement the tool with clinical knowledge to
facilitate assessment of MRPs. In addition, access to PMR was indicated as crucial. Phase
Two showed that the application of the tool was useful specifically for diabetes
management and prompted pharmacists to provide structured and consistent
271
interventions. The suggestions for improvements from this phase led to refinement of
the Simpler™ training modules and the Simpler™ tool hand-out. The barriers and
challenges of pharmacists utilising the tool were acknowledged and informed the
methodology of the next phase.
Once the essential steps in the development and refinement in Phases One and Two
were accomplished, the overall aim of the research was then evaluated moving forward
to Phase Three. Phase Three evaluated the effectiveness of the tool on pharmacists’
evidence-based recommendations including patients’ clinical and health related QOL
through a randomised controlled trial (RCT). Patients were randomised to receiving care
from pharmacists using the Simpler™ tool and to receiving the usual customary care and
were followed up for 6-months. RCT was chosen as the study method as it reduces
selection and confounding biases. In addition, previous studies have recommended this
method to measure the effectiveness of healthcare interventions.(3)
The process involved in Phases One, Two and Three and their findings are summarised
in Figure 6.1.
272
Figure 6. 1: Flow chart shows the summary of research process and finding
• Phase One
• development of tool
• validation using the Delphi process by diabetes
experts (n=12) from Australia and Malaysia
• Phase One findings
• tool validated
• consists of 7 factors and 35 indicators
• Phase Two findings
• improved pre-& post training test
• tool refined
• Phase Two
• development of training package
• online & face to face workshop
• pre-& post training questionnaire
• semi structured interview
• pharmacists from Australia & Malaysia (n=12)
•
• Phase Three findings
• improved clinical and QOL outcomes
• improved medication adherence
• Phase Three
• evaluation of tool
• RCT
• 7 clinics from six districts in Johor, Malaysia
• recruitment of pharmacists (n=14)
• training and support provided throughout trial
• recruitment of patients (n=154)
September
2014
to
December
2014
January
2015
to
August
2015
May
2016
to
March
2017
The primary aim of the trial was to achieve ≥ 1% HbA1c reduction. The reason being, this
level of reduction has been shown to improve patient outcomes with respect to
secondary risk factors.(326) The secondary outcomes of Phase Three of this research
was that patients in the intervention arm showed statistically significant improvement in
FBG, systolic BP, LDL and HDL levels at six months compared to baseline. Overall, HbA1c,
systolic BP and QOL showed significant improvements at six months with respect to the
control arm. Importantly, reductions of >1% HbA1c levels occurred in the intervention
arm. This is a direct result of pharmacists’ interventions using the multifactorial
approach. The findings support the beneficial effects of the Simpler™ tool in improving
medication adherence, increase evidence-based recommendations, clinical as well as
health related QOL outcomes among T2DM patients.
Overall the Simpler™ training program improved pharmacists’ skills, knowledge and
confidence post training in both Phases Two and Three. This correlates with findings
from review studies that concluded the need to upskill pharmacists to deliver quality
diabetes care.(264, 383, 384) Due to the concise format of the Simpler™ tool, prior
training is required for its effective use. Pharmacists used the Simpler™ tool to identify
MRPs in each patient and worked towards resolving the problems. Several studies have
shown that addressing medication adherence problems can improve glycaemia
outcomes.(385) However, a systematic review found that while 22 intervention studies
improved medication adherence, only nine improved both medication adherence and
glycaemic control.(380) This indicates the need for a multifactorial intervention so that
the other diabetes factors involved are addressed. In the Phase Three RCT, the impact
of multifactorial interventions incorporating the seven factors in addition to pharmacists’
expertise on medicine use enhanced the quality of diabetes care pharmacists provided.
Phase Three pharmacists documented 301 MRPs. Of these, 299 (96.3%) interventions to
resolve the problems (including addressing causes of non-adherence) were recorded by
274
both pharmacists and doctors using the Simpler™ template forms. A majority of
pharmacist interventions included evidence-based recommendations to prescribers on
appropriate choice of medications and dosage modifications to achieve optimum
therapy outcomes. Undoubtedly, the validation process in Phase One by diabetes
experts from Australia and Malaysia may have increased pharmacists’ confidence to use
the tool. Pharmacists’ interventions using the Simpler™ tool may have enhanced the
communication process and doctors’ trust in the pharmacists’ recommendations.
Consequently, this could have improved doctor and pharmacist cooperation as
highlighted in a review study on pharmacists’ extended role.(386)
The Simpler™ tool incorporated a template for documentation of information (Simpler™
Pro Forma A) for pharmacists, doctors and nurses to document their interventions on
the same form. Although healthcare professionals (HCPs) are required to document and
communicate patients’ current health status so that the information is available to the
rest of the healthcare team, documentation by HCPs and communication among team
members were found to be inadequate in a systematic review study.(387) The Simpler™
tool on the other hand guided pharmacists to not only make evidence-based
interventions but also to document the interventions. Additionally, the Simpler™ forms
could be sent to doctors by email if further discussion is required and hence enhance
communication between HCP. The Simpler™ tool facilitated the process of HCPs working
towards achieving shared goals. In the practice settings used for the intervention,
doctors were available in the same clinic therefore facilitating better communication.
Although the level of communication may have varied from one clinic to another, the
close housing of pharmacists and doctors may have been an advantage. This would also
be feasible in other general practice settings.
Pharmacists in both Phases Two and Three found the Simpler™ tool feasible and of
benefit in diabetes management. The Simpler tool was designed to be concise and
structured, considering pharmacists’ time constraints. Additionally, the Simpler™ tool
275
was intended to facilitate the process of pharmacist-patient consultation and not to add
additional tasks to their existing MMS process. In addition, the inclusion criteria for
patients recruited into the Phase Three research were aged more than 21 years old, on
multiple medications and HbA1c of more than 8% (63.9 mmol/mol) or fasting blood
sugar > 7.0 mmol/L or two hours post prandial sugar level > 8.5 mmol/L. As such, the
results of the Phase Three RCT could be generalised to patients with similar criteria.
The Simpler™ tool provided specific indicators to address and therapeutic targets to
achieve, whilst also offering individualised, patient centred care. Pharmacists followed
guidelines for less stringent glycaemic targets for patients with severe hypoglycaemia
and advanced complications.(388) In addition, the Simpler tool prompted pharmacists
to address patients’ self-care management. For instance, the education factor in the tool
facilitated each patient to receive education on self-care specifically on areas they need
improvement.(251) The tool is culturally sensitive especially in making dosage
adjustments and when providing counselling advice.
6.2 Conclusions
Pharmacist without specialist diabetes training successfully applied the Simpler™ tool to
improve the primary and secondary outcomes in T2DM. Furthermore, the tool’s
application in the community and primary health care settings was found to be relevant
and feasible in both Australia and Malaysia. The Simpler™ tool was systematically
developed and evaluated to prompt pharmacists to provide structured interventions in
the management of T2DM. Pharmacists as part of collaborative team can use the
Simpler™ tool to provide recommendations to doctors. It is evident that the beneficial
outcomes achieved in this study have been facilitated by a structured and multi-faceted
276
intervention, rather than focusing on a single factor such as patient compliance. With
the increasing prevalence of T2DM worldwide new models for its management need to
be developed and this study has demonstrated that pharmacists using a structured
intervention tool can achieve positive patient outcomes in several domains important to
overall disease management. This approach could be broadened to MMS practices for
T2DM management.
6.3 Future directions
This research identified gaps in the delivery of quality diabetes care. Most diabetes
studies identified, incorporated one or a combination of intervention strategies but not
all seven factors. Systematic review studies that focused on specific intervention
strategies showed improved outcomes although the intervention strategies were
inconclusive or unclear. This research therefore took a multifactorial approach whereby
all seven factors were considered important to achieve the desired outcome.
Considering the learning from this study, the following recommendations are made for
future research.
1. Australia and Malaysia have similar diabetes guidelines and provide diabetes
MMS, which broadens the scope to apply the tool. Using the same premise,
countries with similar diabetes guidelines which include the UK, Europe and the
USA may find the tool beneficial when providing diabetes MMS. Therefore, other
multi centre studies are necessary to evaluate the effectiveness of the tool in
other countries.
2. Although this research evaluated the application of evidence-based
interventions, clinical and QOL outcomes as well as pharmacists’ view on the tool,
277
it did not assess the economic impact, as was proposed by a review study on
pharmacist intervention tools.(389) Future studies should ideally also evaluate
the cost effectiveness of Simpler™ interventions especially in reducing the risk of
hospitalizations or onset of diabetes related complications like nephropathy or
CVD.
3. In this research, Phase Three period was only for six months. Previous long term
studies have shown that patient improvement waned after six months.(158)
Therefore future studies should look into strategies to sustain patient
improvements after the RCT study has ended or involve long term studies. In
addition, the frequency of pharmacist interventions should be considered.
4. Pharmacists’ expanding role and delivery of new services are currently moving
towards the need for collaborative drug therapy management (CDTM) as
opposed to current medication management services (MMS).(118) In CDTM,
pharmacists independently change, add and modify doses of medications as part
of an agreed protocol with the prescriber and other members of the healthcare
team. The Simpler™ tool contains a list of guideline-based indicators which CDTM
pharmacists working in collaboration with general practitioners could utilise to
make medication changes. In addition, the Simpler™ tool could be used to assist
pharmacist deliver structured intervention during remote monitoring such as
telemedicine or tele pharmacy.(390)
5. The pharmacists in Phase Two identified that access to patients’ medical record
was necessary for efficient use of the Simpler™ tool. In other pharmacy services,
such as home medication review, pharmacists’ access to PMRs may enable
pharmacists to utilise the Simpler™ tool more efficiently.
6. The tool has not been evaluated among privately owned community pharmacy
settings in Malaysia. Future studies can explore its effectiveness in this setting.
279
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“Every reasonable effort has been made to acknowledge the owners of copyright material. I
would be pleased to hear from any copyright owner who has been omitted or incorrectly
acknowledged.”
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School of Pharmacy
GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769 Email pharmacy@curtin.edu.au Web curtin.edu.au
Appendix 3. 2: Phase One participant information sheet
INFORMATION SHEET
Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study Purpose of the study? As part of my PhD I need to evaluate a diabetes tool called the SIMPLER tool. This tool will be used to facilitate pharmacists in making structured, consistent and quality interventions.
What will the study involve? The study will involve completing a series of surveys to evaluate the use of the SIMPLER tool. This is expected to take a maximum of 30 minutes for each survey. The first survey will involve ranking each category of indicators for diabetes management as they should appear in the accompanying hand-out. In addition, participants will be required to rank indicators not previously included in diabetes guidelines and whether they should be included in the SIMPLER tool. Group consensus will be achieved when 60% or more respondents give the same response to a question.
Why have you been asked to take part? You have been asked because of your expertise and vast experience in diabetes.
Do you have to take part? The answer is no! Participation is voluntary. You have the option of withdrawing before the study commences or discontinuing after data collection has started without penalty.
Will your participation in the study be kept confidential? Yes. The identity of each participant will not be revealed to other participants. Any information about your identity will not appear in the thesis or publications. Any extracts from your comments will be entirely anonymous.
What will happen to the information which you give? The data will be kept confidential for the duration of the study and up to 5 years post completion of the study. On completion of the thesis, they will be retained for a further six months and then destroyed.
What will happen to the results? The results will be presented in the thesis and publications. They will be seen by my supervisor, a second marker and the external examiner. The thesis may be read by future students in the course.
What are the possible disadvantages of taking part? I don’t envisage any negative consequences for you in taking part.
Who has reviewed this study? Approval must be given by the Faculty of Health and Science, Curtin University, Bentley, Western Australia before the survey takes place. Curtin University conducts research in accordance with the National Statement on Ethical Conduct in Human Research.
Any further queries? If you need any further information, you can contact me: Shamala Ayadurai, shamala.ayadurai@postgrad.curtin.edu.au
This study has been approved under Curtin University’s process for lower-risk studies (Approval Number PH-18-14). This process complies with the National Statement on Ethical Conduct in Human Research (Chapter 5.1.7 and Chapters 5.1.18-5.1.21). For further information on this study contact the researchers named above or the Curtin University Human Research Ethics Committee. C/- Office of Research and Development, Curtin University, GPO Box U1987, Perth 6845 or by telephoning 9266 9223 or by emailing hrec@curtin.edu.au.
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Appendix 3. 4: Round 1 questionnaire 1. Below is a list of diabetes indicators recommended by diabetes guidelines from Malaysia,
Australia, America, and the United Kingdom. The questionnaire is divided into two parts.
In Part I you are asked to rate each of the indicators in order of importance as it should
appear in the accompanying hand-out (appendix). Note that 1 is ranked as most
important and will appear as the first subheading, 2 as the second subheading, and 3 as
the third subheading and so on. Only one number can be circled per subheading. In
formulating your responses, you are not expected to assess the feasibility or cost of
monitoring the indicators. The table below shows an example of this:
Code: Indicator Name And Description
Appearance Of Indicator In Hand-out In Order Of Importance.
Please Choose One Number For Each Indicator. The Same Number Cannot Be Picked More Than Once For Each Of The Indicator.
Order of appearance in hand-out
1. 3.3 Statin initiation in patients with CVD
□1 2 □ 3 This will be the second bullet point to appear in the hand-out (appendix3).
2. 3.4 Statin initiation in patients over age 40 years without CVD
1 □2 □ 3 This will be the first bullet point.
3. 3.5 Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.5mmol/L), TG (<1.5mmol/L).
□1 □2 3 This will be the third bullet point.
2. In Part 2 of the questionnaire, you are asked to rate the indicator in terms of its value in
making diabetes interventions, where 1 indicates it is least important or redundant and
5 indicates it is most important.
3. Once consensus is achieved, these indicators will appear in the hand-out. This hand-out
will be used to aid pharmacists to make their interventions.
4. A space is provided for you to briefly explain the reason for your rating if you wish to.
This additional information is optional and could help us understand the reasons some
indicators receive a more important ranking than others. The space could also be used
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for additional suggestions or interventions that should be included according to
indications mentioned.
5. As the Simpler™ tool is quite unique, we would like to stress that all materials discussed
here will remain the intellectual property of the researchers and protected by copyright
laws. All such rights are reserved. Materials may not be reproduced, distributed or
otherwise exploited in any manner without prior written permission.
Part 1
Code Indicator Name And Description Appearance of indicator in hand-out in order of importance.
Please choose one number for each indicator. The same number cannot be picked more than once for each of the indicator.
Additional Comments
Statin Initiation: 3 indicators
3.6 Statin initiation in patients with CVD ☐1 ☐2 ☐3 Click here to enter text.
3.7 Statin initiation in patients over age 40 years without CVD
☐1 ☐2 ☐3 Click here to enter text.
3.8 Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.5mmol/L), TG (<1.5mmol/L).
☐1 ☐2 ☐3 Click here to enter text.
Insulin Initiation: 6 indicators
3.9 Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 Click here to enter text.
3.10 Management of hypoglycaemia ☐1 ☐2 ☐3 ☐4 ☐5 ☐6 Click here to enter text.
3.11 Self-monitoring of blood glucose Malaysia & Australia CPG (4.0-6.0mmol/L fasting); NHMRC (6-8mmol/L (fasting), (6-10mmol/L, 2h postprandial). Malaysia CPG (6-8mmol/L-2h postprandial)
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 Click here to enter text.
3.12 Target of HbA1c ≤ 7% (53mmol/mol) if no other complications
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 Click here to enter text.
3.13 Aim a reduction of HbA1c by 1% ☐1 ☐2 ☐3 ☐4 ☐5 ☐6 Click here to enter text.
Initiate metformin if not contraindicated ☐1 ☐2 ☐3 ☐4 ☐5 ☐6 Click here to enter text.
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Medication: 2 indicators
3.14 Review medication adherence using 8- items modified Morisky medication adherence scale
☐1 ☐2 Click here to enter text.
3.15 Assess medicine related problems(pharmacotherapy): contraindicated medicine, inappropriate dosing, adverse reaction, duplication of therapy, medicine and food interaction, unnecessary medicine use
☐1 ☐2 Click here to enter text.
Blood Pressure (BP) Control: 5 indicators
3.16 BP target: ≤130/80 ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
4.2 Reduce sodium intake ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
4.3 ACEI/ARB initiation in patients without microalbuminuria/proteinuria
☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
4.4 ACEI/ARB initiation in patients with microalbuminuria/proteinuria
☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
Lifestyle Intervention: 8 indicators
5.1 Moderate alcohol intake: ≤2 standard drinks (20g) per day for men and women with max 4 standard drinks on any occasion
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8 Click here to enter text.
5.2 Exercise: 30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8 Click here to enter text.
5.3 Smoking cessation ☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8 Click here to enter text.
5.4 Advice on foot care ☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8 Click here to enter text.
5.5 Weight loss: Australia (BMI<25kg/m2 ) Malaysia (BMI <23kg/m2)
☒1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8 Click here to enter text.
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Waist circumference Australia (<94cm in men,<80cm in women, waist circumference), Malaysia ( ≤90cm in men,≤80cm in women)
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8
Click here to enter text.
5.7Erectile dysfunction: recommend PDE-5 inhibitor as first line therapy for male patients
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8 Click here to enter text.
5.8Management of stress & diabetes related distress
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 ☐8 Click here to enter text.
Education: 3 indicators
6.1 Knowledge and understanding of medicine
☐1 ☐2 ☐3 Click here to enter text.
6.2 Medicine storage ☐1 ☐2 ☐3 Click here to enter text.
6.3 Medication optimisation during fasting month for muslims
☐1 ☐2 ☐3 Click here to enter text.
CVD Risk factors: 3 indicators
7.1 Aspirin therapy (75mg-162mg/day) as primary prevention to decrease CVD risk (10 year risk>10%, Framingham)
☐1 ☐2 ☐3 Click here to enter text.
7.2 Aspirin therapy as secondary prevention in those with diabetes with history of CVD
☐1 ☐2 ☐3 Click here to enter text.
7.3 Use of Framingham risk calculatorto calculate CVD risk and educate patient
☐1 ☐2 ☐3 Click here to enter text.
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Part 2
Code: Indicator Name And Description Rating (1=least preferred 5=most preferred)
Please choose your preference.
8. Hand-out Design Preference
8.1 Appendix 3a (bookmark design) ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
8.2 Appendix 3b ( wheel design) ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
9. Additional Indicators to be included in hand-out Rating (1=least preferred 5=most preferred)
Please choose your preference.
9.1 Administer once daily antihypertensive at bedtime ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
9.2 Diet advice using plate model ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
9.3 Annual eye assessment ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
9.4 Address sleep hygiene ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
9.5 1g-3g cinnamon intake per day ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
9.6 Vitamin B12 supplement in patients on long term metfomin ☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
9.7 Encourage daily Intake of tree nuts (almonds, brazil nuts, cashews, hazelnuts, macadamia, pecans, pine nuts, pistachios and walnuts)
☐1 ☐2 ☐3 ☐4 ☐5 Click here to enter text.
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Appendix 3. 5: Excerpt from Round 2 Questionnaire Code Indicator Name And Description
Part 1
Your Score
Median Score
Round 2 Score
Please choose one number for each indicator. The same number cannot be picked more than once for each of the indicator.
1. Statin Initiation: 3 indicators
1.1 Statin initiation in patients with CVD 2 1 ☐1 ☐2 ☐3
1.2 Statin initiation in patients over age 40 years without CVD
3 3 ☐1 ☐2 ☐3
1.3 Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.5mmol/L), TG (<1.5mmol/L).
1 2 ☐1 ☐2 ☐3
Code: Indicator Name And Description
Part 2
Your Score Median Score
Round 2 Score (1=least preferred 5=most preferred)
Please choose your preference.
8. Hand-out Design Preference
8.1 Appendix 3a (bookmark design) 3 4 ☐1 ☐2 ☐3 ☐4 ☐5
8.2 Appendix 3b ( wheel design) 5 3 ☐1 ☐2 ☐3 ☐4 ☐5
Appendix 3. 7: Excerpt from Round 3 questionnaire Code Indicator Name And Description
Part 1
Your Score
Median Score
Round 2 Score
Please choose one number for each indicator. The same number cannot be picked more than once for each of the indicator.
1. Statin Initiation: 3 indicators
3.17 Statin initiation in patients with CVD
1 1 ☐1 ☐2 ☐3
3.18 Statin initiation in patients over age 40 years without CVD
consensus achieved 3
3.19 Achieve targets: LDL, Malaysia (LDL<2.6mmol/L, TG<1.7mmol/L) Australia (LDL<2.5mmol/L), TG (<1.5mmol/L).
3 2 ☐1 ☐2 ☐3
9. Additional Indicators to be included in hand-out Part 2
Your
Score
Median
Score
Round 2 Score (1=least preferred 5=most preferred)
Please choose your preference.
9.5 1g-3g cinnamon intake per day 2 1 ☐1 ☐2 ☐3 ☐4 ☐5
9.6 Vitamin B12 supplement in patients on long term metfomin
1 2 ☐1 ☐2 ☐3 ☐4 ☐5
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Appendix 4. 3: The Simpler™ training modules outline
MODULE 1- INTRODUCTION (15 MINS)
Learning Objectives
• Describe the pharmacist’s role in management of Type 2 Diabetes Mellitus
• Explain the research objectives and significance
• Outline the research plan and present results of the Phase 1 study
Content
• Introduction on research objectives
• Background information on prevalence of diabetes in Australia & Malaysia
• Phase 1 Delphi results
Process
Presentation 15 minutes
Resources
Slides
MODULE 2- SIMPLER™ VALIDATION (30 MINS)
Learning Objectives
• Outline and describe the seven indicators incorporated into Simpler™
• Explain the benefits of Simpler™ using evidence-based information
Content
• Simpler™ diabetes indicators
• Additional indicators: findings from Phase 1
• Recent updates on diabetes management
Process
Presentation 30 minutes
Resources
Slides
MODULE 3 – CASE SCENARIO (45 MINS)
Learning Objectives
• Outline the information gathering process
• Practise effective intervention using the Simpler™ tool
Content
• Extracting information from patient and case notes
• Systematic intervention using the Simpler™ tool
Process
Presentation 15 minutes
Resources
Case study
Case study (1 scenario) 1. Participants to practise intervention using Simpler™
2. Feedback 30 minutes
Diabetes Guidelines
Simpler™ tool
MODULE 4 – WRITING INTERVENTION NOTES (30 MINS)
Learning Objectives
Writing case notes using the Simpler™ tool
Content
• Legal aspects
• Describing observations and interventions
• Use of correct spelling and grammar.
• Writing case note using the Simpler™ tool
Process
Presentation 15 minutes
Resources
Slides
Case study (1 scenario) 1. Documenting patient case notes
Diabetes Guidelines and Simpler™ tool
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Appendix 4. 7: Introductory letter to Phase Two participants
26 March 2015
Dear Pharmacist,
Diabetes is a complex disease and there are many factors involved in treating and preventing diabetes related complications. Many of these factors are based on findings from landmark randomised controlled trials and have been incorporated into diabetes guidelines. Yet, evidence suggests that diabetes patients do not always receive diabetes care according to the guidelines. We are conducting research that involves the development and evaluating of a patient-centred diabetes tool, called the Simpler™ tool, to be used by pharmacists to facilitate making structured interventions.
Our research will involve a two-hour training session on the Simpler™ tool. Trained pharmacists will then be given a month to use the Simpler™ tool in their own practices setting. This will be followed by an exploratory interview to obtain feedback about the use and feasibility of the Simpler™ tool. This interview will take approximately 30 minutes and will be conducted by Shamala Ayadurai who is undertaking this research to meet the requirements of the Doctor of Philosophy. Your participation is completely voluntary. If you choose to participate you will receive remuneration of AUD$100 (AUD$50 for Malaysian participants) as a token of our appreciation for your time and effort.
If you have any questions about our research, we are more than happy to provide you with the necessary information.
Thanking in advance for your time and consideration.
Yours sincerely,
Shamala Ayadurai Dr. Laetitia Hattingh PHD Candidate PhD Supervisor and Senior Lecturer School of Pharmacy, Curtin University School of Pharmacy, Curtin University Perth, Western Australia Perth, Western Australia Tel: 04 50602642 Tel: +61 892667376 Email:shamala.ayadurai@postgrad.curtin.edu.au
Email: L.Hattingh@curtin.edu.au
This study has been approved by the Curtin University Human Research Ethics Committee (Approval Number RDHS-06-14). The Committee is comprised of members of the public, academics, lawyers, doctors and pastoral carers. If needed, verification of approval can be obtained either by writing to the Curtin University Human Research Ethics Committee, c/- Office of Research and Development, Curtin University, GPO Box U1987, Perth, 6845 or by telephoning 9266 2784 or by emailing hrec@curtin.edu.au
School of Pharmacy
GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769 Email pharmacy@curtin.edu.au Web curtin.edu.au
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Appendix 4. 8: Phase Two participant information sheet
School of Pharmacy
GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769
Emailshamala.ayadurai@ postgrad.curtin.edu.au
Webcurtin.edu.au
INFORMATION SHEET Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study Purpose of the study? My name is Shamala and I am a PhD student at the School of Pharmacy, Curtin University. As part of my PhD I need to evaluate a diabetes tool called the Simpler™ tool. This tool will be used by pharmacists to facilitate making structured interventions. What will the study involve? The study will involve the use of the SIMPLER training modules to train five community pharmacists in Western Australia and five primary health care pharmacists in Malaysia as part of a pilot study. The training session will takeapproximately two hours. The training modules will be evaluated through pre- and post-training questionnaires. The questions will test the pharmacists on knowledge and practice behaviour on evidence-based diabetes care. Trained pharmacists will then have one month to use the tool, followed by a qualitative interview which will take approximately 30 minutes to explore the usefulness of the tool. Why have you been asked to take part? You have been asked because of your expertise and experience in diabetes management. Do you have to take part? The answer is no! Participation is voluntary. You have the option of withdrawing before the study commences or discontinuing after data collection has started without penalty. Will your participation in the study be kept confidential? Yes. The identity of each participant will not be revealed to other participants. Any information about your identity will not appear in the thesis or publications. Any extracts from your comments will be entirely anonymous. What will happen to the information which you give? The data will be kept confidential for the duration of the study and up to 5 years post completion of the study. On completion of the thesis, they will be retained for a further six months and then destroyed. What will happen to the results? The results will be presented in the thesis and publications. They will be seen by my supervisor, a second marker and the external examiner. The thesis may be read by future students in the course. What are the possible disadvantages of taking part? I don’t envisage any negative consequences for you in taking part.
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Who has reviewed this study? Approval must be given by the Faculty of Health and Science, Curtin University, Bentley, Western Australia before the survey takes place. Curtin University conducts research in accordance with the National Statement on Ethical Conduct in Human Research. Approval must also be given by Medical Research and Ethics Committee, MREC, Ministry of Health, Malaysia. . Any further queries? If you need any further information, please contact my Principal Supervisor Dr Laetitia Hattingh at l.hattingh@curtin.edu.au This study has been approved by the Curtin University Human Research Ethics Committee (Approval Number: RDHS-06-14). The Committee is comprised of members of the public, academics, lawyers, doctors and pastoral carers. If needed, verification of approval can be obtained either by writing to the Curtin University Human Research Ethics Committee, c/- Office of Research and Development, Curtin University, GPO Box U1987, Perth, 6845 or by telephoning 9266 2784 or by emailing hrec@curtin.edu.au
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Appendix 4. 9: Phase Two consent form
School of Pharmacy
GPO Box U1987 Perth Western Australia 6845
Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769
Emailshamala.ayadurai@postgrad.curtin.edu.au Webcurtin.edu.au
Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study Consent Form I, …………………………………………. agree to participate in the above study. I have been provided with a copy of the Participant Information Sheet explaining the study, which I have read and understood. I have been given the opportunity to ask questions about the study and any questions asked have been answered to my satisfaction. I understand that I may withdraw from the study at any time without prejudice. I am aware that all research data collected will only be used for the purpose of this study and will be kept confidential and that my participation will not be disclosed without my consent. Any information which might potentially identify me will not be used in published material.
Signed:
………………………………………..
Date:
………………………
Signature of person
obtaining consent:
…………………………………………
Date:
……………………….
Name of person
obtaining consent:
Shamala Ayadurai
Receipt of Gift Card I declare that I have received AUD$100/AUD$50 gift card as a token of appreciation for my time to participate in the study.
Signed:
………………………………………..
Date:
………………………
Signature of person
giving out gift card:
…………………………………………
Date:
……………………….
Name of person
giving out gift card:
………………………………………….
Contact Information For further information contact Shamala Ayadurai(Mobile: 0450602642 or email shamala.ayadurai@postgrad.curtin.edu.au) This study has been approved by the Curtin University Human Research Ethics Committee (Approval Number RDHS-06-14). The Committee is comprised of members of the public, academics, lawyers, doctors and pastoral carers. If needed, verification of approval can be obtained either by writing to the Curtin University Human Research Ethics Committee, c/- Office of Research and Development, Curtin University, GPO Box U1987, Perth, 6845 or by telephoning 9266 2784 or by emailing hrec@curtin.edu.au
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Appendix 4. 10: Pre-and post training questionnaire
Instructions
1. This Pre and Post training questionnaires contains two sections: (1) Section A and (2) Section B
2. Section A focuses on participants’ training background and current practice.
3. Section B covers knowledge and use of current diabetes guidelines in managing patients with diabetes. It consists of open ended questions based on a case scenario.
4. Participants will answer Sections A and B before the training session and Section B again after the training session.
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Simpler™ tool Pre-training Questionnaire
SECTION A
The first section gathers some basic information about your training background and current practice. 1. Have you had any specific diabetes management education or training after your initial
pharmacy degree training?
2. NO (go to Q3)
3. YES
2. If you answered YES to the above question, please provide details of education and
training/qualification, when it was undertaken and how many hours it involved.
Name of training/Institution where the training was conducted
When completed
Duration (eg.hours,months,years)
3. How long have you been a registered pharmacist?
0-1 years
More than 1 year but less than 3 years
3-5 years
>5 years
4. How long have you practising as MTAC Diabetes/ Diabetes MedsCheck/Endocrine Ward
Pharmacist?
0-1 years
More than 1 year but less than 3 years
3-5 years
>5 years
5. What motivated you to participate in this research? (Rank from 1 to 5; where 1 = most
motivating and 5 = least motivating).
Obtaining CPD points
Financial reimbursement
Interest in the subject
It was recommended to me
I want to improve patient outcomes
Others. Please specify_________________
ID:
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Simpler™ tool Pre-training Questionnaire
SECTION B
This section covers your knowledge and skills about working with people with diabetes. As this is not a test PLEASE do not check resources to answer the questions. Please answer the questions based on the case scenario below.
Lily is a 54-year-old teacher, with a six year history of type 2 Diabetes
Mellitus (DM). Her medical record details are as below:
Laboratory test results
Average Fasting Blood Glucose: 9 mmol/l
Average 2 hr post prandial blood glucose: 14 mmol/l
Recent HbA1c: 10% (85.8mmol/mol)
BP: 144/95 mmHg
TG: 3.1 mmol/L(<1.69 mmol/L)
LDL: 3.1 mmol/L (<4 mmol/L)
HDL: 0.94 mmol/L (0.9-1.9
mmol/L)
Kidney and Liver Function Tests are normal
Medications
1. Gliclazide 160 mg bd 2. Amlodipine 10 mg od 3. Simvastatin 20 mg nocte 4. Metformin 1 g tds
ID:
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1. What additional information about Lily do you need to know in order to manage her diabetes more effectively? Answers ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------
2. What interventions would you recommend for this patient and give your reasons? Answers ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------
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Simpler™ tool Post-training Questionnaire
SECTION B
This section covers your knowledge and skills about working with people with diabetes. As this is not a test PLEASE do not check resources to answer the questions. Please answer the questions based on the case scenario below.
Lily is a 54 year old teacher, with a six year history of type 2 Diabetes
Mellitus (DM). Her medical record details are as below:
Laboratory test results
Average Fasting Blood Glucose: 9 mmol/l
Average 2 hr post prandial blood glucose: 14 mmol/l
Recent HbA1c: 10% (85.8mmol/mol)
BP: 144/95 mmHg
TG: 3.1 mmol/L(<1.69 mmol/L)
LDL: 3.1 mmol/L (<4 mmol/L)
HDL: 0.94 mmol/L (0.9-1.9
mmol/L)
Kidney and Liver Function Tests are normal
Medications
1. Gliclazide 160 mg bd 2. Amlodipine 10 mg od 3. Simvastatin 20 mg nocte 4. Metformin 1 g tds
ID:
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1. What additional information about Lily do you need to know in order
to manage her diabetes more effectively? Answers ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------
2. What interventions would you recommend for this patient? Answers ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------
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Appendix 4. 11: Marking scheme for pre-and post training questionnaire (trial
version)
Simpler™ tool Training Questionnaire
SECTION B
This section covers your knowledge and skills working with people with diabetes. As this is not a test PLEASE do not check resources to answer the questions. Considering the case scenario below please answer the questions. Lily is a 54 year old teacher, with a six year history of type 2 Diabetes Mellitus (DM). Her record summary sheet is as below: Patient Details Average Fasting Blood Glucose: 9 mmol/l Average 2 hr post prandial blood glucose: 14 mmol/l Recent HbA1c: 10% (85.8mmol/mol) BP: 144/95 mmHg TG: 3.1 mmol/L(<1.69mmol/L) LDL: 3.1 mmol/L (<4mmol/L) HDL: 0.94 mmol/L(0.9-1.9mmol/L) Kidney and Liver function tests are normal Medications: 1. Gliclazide 160mg bd 2. Amlodipine 10mg od 3. Simvastatin 20mg nocte 4. Metformin 1g tds 3. What additional information about Lily do you need to manage her diabetes more effectively? Answers a) Allergies: Lily claims NKDA b) Family history: Mother has Type 2 DM and died from myocardial
infarction aged 74 c) Weight: 67 d) Height:1.52m e) Alcohol: 22 units per week f) Smoking: 10 cigarettes per day g) Rarely exercise h) Traditional medications: Chinese herbal pills for energy i) Medication adherence: 8-items MMMAS = 5.5, L has missed several
doses while out with friends, has difficulty remembering to take medications sometimes, finds troublesome to stick to treatment plan.
ID:
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j) Suffered from hypoglycaemia twice last month mainly in the middle of the night
k) Finds blood glucose monitoring strips expensive, so rarely monitors blood glucose
l) Knowledge, time, dose, Frequency of medication administration m) Total cholesterol: 4 mmol/L What interventions would you recommend for this patient? Answers a) Address compliance issues b) Start insulin, insulatard 10unit on or start DPP 4 inhibitor(sitagliptin 100mg od) minimal weight gain and hypoglycaemia c) Dose of metformin 1g bd or combination sitagliptin & metformin d) Stop gliclazide if suspect causing hypoglycaemia e) Simvastatin 40mg od f) Start ACE Inhibitor, perindopril 4mg od g) Education to prevent hypoglycaemia h) Education on SBMG, foot care i) Exercise, smoking, alcohol j) Address traditional medication k) Aspirin needed based on Framingham CVD risk score (16% Australian absolute CVD risk calculator, Framingham risk score 15.9%) l) Insulin technique and management
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Appendix 4. 12: Marking scheme for pre and post training questionnaire (revised)
Simpler™ tool Marking Scheme for Training Questionnaire
Lily is a 54-year-old teacher, with a six-year history of type 2 Diabetes Mellitus (DM). Her record summary sheet is as below: Patient Details Average Fasting Blood Glucose: 9 mmol/l Average 2 hr post prandial blood glucose: 14 mmol/l Recent HbA1c: 10% (85.8mmol/mol) BP: 144/95 mmHg TG: 3.1 mmol/L (<1.69mmol/L) LDL: 3.1 mmol/L (<4mmol/L) HDL: 0.94 mmol/L (0.9-1.9mmol/L) Kidney and Liver function tests are normal Medications: 1. Gliclazide 160mg bd 2. Amlodipine 10mg od 3. Simvastatin 20mg nocte 4. Metformin 1g tds
1. What additional information about Lily do you need to manage her diabetes more effectively?
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No. Answers Marks
1. Allergies,
Previous adverse drug reaction 1
2. Any hypoglycaemia?
SMBG results
Monitoring knowledge eg measures correct time of day
2
3. Address compliance issues using 8MMMAS
Address issues with traditional medication if any (possible interaction with modern medication)
If current medications are causing side effects?
2
4. Sodium intake 1
5. Alcohol,
Smoking,
Exercise,
Weight & Height,
Waist Circumference
Diet,
stress,
sleep hygiene
eye assessment
foot care
3
6. Knowledge, time, dose, frequency of medication administration, 1
Medication storage 1
7. CVD risk using Framingham Risk Calculator
Total Cholesterol
Family history
2
Total 13
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2. What interventions would you recommend for this patient?
Answers Marks
S Add ezetimibe 10mg od to lower LDL and TG. (Reduce LDL by 47% according to data by FDA drug safety communication).
Change Simvastatin 20mg to Atorvastatin 20mg (reduce LDL by 41%).
1
I Start insulin, insulatard 10units ON or start DPP4inhibitor (sitagliptin 100mg od causes minimal weight gain and hypoglycaemia)
Dose of metformin should be 1g bd /To improve compliance can suggest combination of sitagliptin & metformin
Reduce dose of gliclazide to 80mg bd
Counsel patient on insulin technique and management
Counsel patient on monitoring blood glucose (SMBG)
3
M Address compliance issues Address compliance issues using 8MMMAS
Address issues with traditional medication if any (possible interaction with modern medication)
If current medications are causing side effects suggest suitable alternative
2
P Start ACE inhibitor or ARB, eg perindopril 4mg od, as BP>130/80 1
Sodium intake 1
L Address the following:
BMI
Waist Circumference
Alcohol,
Smoking,
Exercise,
Diet,
stress,
sleep hygiene
eye assessment
foot care
3
E Education to prevent hypoglycaemia and management of hypoglycaemia (rule of 15)
Knowledge, time, dose, frequency of medication administration
Storage of medication
2
R Aspirin 75mg od needed based on Framingham CVD risk score according to American Diabetes Guidelines 2015 1
Total 14
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Appendix 4. 13: Interview guide
Interview Guide: Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study Thank you for taking the time to talk to me today. To start off, I will give a brief summary. The key question is will a diabetes tool increase the number of patients receiving guideline-adherent therapy. I understand you have been using this tool for about a month in patients during Diabetes MedsCheck/MTACDM. In particular, I will be asking questions about the practicability and ease of use of this tool. I have a series of questions to help guide the interview. There are no wrong answers to these questions, feel free to share your point of view and experience. Everything you say will remain confidential and your name will not appear in any reports or publications. I would like to record this, so we can focus on our discussion. Do you agree with me recording the interview? Section A: Details and experience of Pharmacist
1. 1. What is your age?
2. 2. Were you trained to practise Diabetes MedsCheck/ MTAC diabetes?
3. 3. If yes, how did you undertake this training?
4. 4. Do you have any post-graduate qualifications? If yes, what qualifications?
5. 5. On average, how many hours do you work per week in the community setting?
6. 6. How many years have you been practising as a pharmacist in the community?
7. 7. In which year did you first obtain your registration to practise as a pharmacist?
8. 8. How would you consider your current role in the pharmacy?
9. Prompt: Dispensary pharmacist, patient care-focused, managerial role, MTAC pharmacist, clinical pharmacist….
Section B: Experience in providing Diabetes MedsCheck service before being trained on Simpler™ tool
1. 1. On average, how many patients do you provide Diabetes
MedsCheck service to in a day/week/month?
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2. 2. How do you normally review patients?
Prompt: use MTAC diabetes/Diabetes MedsCheck checklist,
own checklist, tools from the web, etc
3. 3. How often do you refer to the Australian Diabetes
Guidelines/Malaysia CPG on diabetes?
Section C: Experience in using Simpler™ tool
1. Please comment on your experience in using the Simpler™ tool.
Prompts:
a. a. Relevance when reviewing patient?
b. b. Ease of Use? Content simple to understand?
c. c. Relevance to local practice and guidelines?
d. d. Managing consultation time with patients?
e. e. Intervention format?
f. f. Ease of remembering?
g. g. Guide pharmacists to make interventions?
h. h. Record intervention notes in a consistent, structured manner?
i. i. Clarity of tool?
j. j. Providing evidence-based information to GP, patients?
2. How many patients did you use SIMPLER on?
3. Talk about the interventions you made using SIMPLER?
4. Are the medication reviews with patients with diabetes different now
compared to when you were not using the Simpler™ tool? If yes in
what way?
5. How was the SIMPLER training session?
6. Would you recommend Simpler™ tool to other community
pharmacists?
7. Are they any recommendations you like to make to enhance the
usability of the tool?
8. Thank you again for your time. Before we finish, do you have any
comments you’d like to make, about the research topic or training or
about the interview?
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Appendix 5. 5: Phase Three pharmacist information sheet (pharmacist)
School of Pharmacy
GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769
Emailshamala.ayadurai@ postgrad.curtin.edu.au
Webcurtin.edu.au
INFORMATION SHEET FOR PHARMACISTS
Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed
Methods Study
1. What is this study about? This research aims to develop and evaluate a decision-support tool to support pharmacists in delivering diabetes care at primary health care settings in Malaysia. We will investigate the effectiveness of the tool to improve control of blood glucose, blood pressure and cholesterol levels as well as quality of life. We will also determine the potential cost effectiveness of the tool compared to usual care.
2. Who is doing this research? Dr. Laetitia Hattingh, Prof.Bruce Sunderland and Associate Prof.Dr.Lisa Tee from Curtin University in Western Australia and chief pharmacist of Sultanah Aminah Hospital, Johor Bahru, Dr.Siti Norlina Md Said in Malaysia are supervising this project. The results of this study will be used by Shamala Ayadurai as part of her PhD project.
3. Why am I being invited to participate and what do I have to do? You have been invited to participate because you are involved in diabetes management. Your involvement in this research will start with a 2 hour training session on the use of this tool. Each primary health clinic (Klinik Kesihatan) will be asked to recruit 20 patients who will be followed up for six months. These 20 patients will be randomised to two arms: 10 patients for the intervention and 10 patients for the control arm. Pharmacists will administer the health related quality of life questionnaire to the 20 patients (intervention and control arm) twice, once in the beginning and again at the end of six months. A scanned copy of the completed questionnaire will be sent via email to the researcher, Shamala Ayadurai. The patients in the intervention arm will be followed up every month for six months while the patients in the control arm will only be seen twice by the intervention pharmacist namely once in the beginning and once at the end of the six months. Pharmacists will be asked to use the diabetes tool to suggest interventions to doctors. Pharmacists will take an image of their intervention notes and patients’ laboratory data and send it via email to Shamala every month for recording in a data collection form. As for patients in the control arm, image of patients’ demographic data and laboratory data will be sent to Shamala at the beginning and once more at the completion of the study at 6 months. As a token of your time and effort, you will receive a remuneration of AUD100/RM300.
4. What are the possible disadvantages of taking part? You may spend more time to consult with patients when using the tool in the beginning of the research project.
5. Who has access to my information and what will happen to it after the project ends? The identity of each participant will not be revealed to other participants. Any information we collect will be treated as confidential and used only in this project. The data we collect in this study will be kept under secure conditions at Curtin University for 25 years after the research has ended and then it will be destroyed. The results of this research may be
362
presented at conferences or published in professional journals, but you will not be identified in any results that are published and you will remain anonymous.
6. Do I have to participate and how can I withdraw? Taking part in a research project is voluntary. It is your choice to take part or not. You do not have to agree if you do not want to. If you decide to take part and then change your mind, that is okay, you can withdraw from the project. You do not have to give us a reason; just tell us that you want to stop. Please let us know you want to stop so we can make sure you are aware of any thing that needs to be done. If you chose not to take part or start and then stop the study, it will not affect your relationship with the university, staff or colleagues. If you chose to leave the study we will use any information collected unless you tell us not to.
7. Any further queries? If you would like to know more at any stage, please do not hesitate
to contact Shamala at shamala.ayadurai@postgrad.curtin.edu.au or Dr.Laetitia Hattingh L.Hattingh@curtin.edu.au or The Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number 03- 22874032. Curtin University Human Research Ethics Committee (HREC) has approved this study (HR214/2015). The
Malaysian Medical Research and Ethics Committee has also approved the study (NMRR-15-1831-28307).
Should you wish to discuss the study with someone not directly involved, in particular, any matters concerning
the conduct of the study or your rights as a participant, or you wish to make a confidential complaint, you may
contact the Ethics Officer on (08) 9266 9223 or the Manager, Research Integrity on (08) 9266 7093 or email
hrec@curtin.edu.au.
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Appendix 5. 6: Phase Three pharmacist consent form
School of Pharmacy
GPO Box U1987 Perth Western Australia 6845
Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769
Emailshamala.ayadurai@postgrad.curtin.edu.au Webcurtin.edu.au
Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study Consent Form I, …………………………………………. agree to participate in the above study. I have been provided with a copy of the Participant Information Sheet explaining the study, which I have read and understood. I have been given the opportunity to ask questions about the study and any questions asked have been answered to my satisfaction. I understand that I may withdraw from the study at any time without prejudice. I am aware that all research data collected will only be used for the purpose of this study and will be kept confidential and that my participation will not be disclosed without my consent. Any information which might potentially identify me will not be used in published material.
Signed:
………………………………………..
Date:
………………………
Signature of person
obtaining consent:
…………………………………………
Date:
……………………….
Name of person
obtaining consent:
Shamala Ayadurai
Receipt of Gift Card I declare that I have received AUD$100/AUD$50 gift card as a token of appreciation for my time to participate in the study.
Signed:
………………………………………..
Date:
………………………
Signature of person
giving out gift card:
…………………………………………
Date:
……………………….
Name of person
giving out gift card:
………………………………………….
Curtin University Human Research Ethics Committee (HREC) has approved this study (HR214/2015). The
Malaysian Medical Research and Ethics Committee has also approved the study (NMRR-15-1831-28307). Should
you wish to discuss the study with someone not directly involved, in particular, any matters concerning the conduct
of the study or your rights as a participant, or you wish to make a confidential complaint, you may contact the Ethics
Officer on (08) 9266 9223 or the Manager, Research Integrity on (08) 9266 7093 or email hrec@curtin.edu.au.
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Appendix 5. 11: The Simpler™ Pro forma A
Time:___________ Date:___________
Simpler™ Pro Forma A (to be used during doctor’s appointment)
Patient ID:_____Visit No:_____
Patient RN:________
Blue Ink: Nurse Purple Ink: Pharmacist Black Ink: Doctor
Gender Age Ethnic Drug allergies
FHx of diabetes
Current social Hx Other diseases
Medicines list: Current, regular, ‘prn’ (taken when necessary) medicines including prescription, non-prescription and complementary medicines
Name Dose Frequency
Statin/Cholesterol control
Subjective & Objective observations: TC=_______mmol/L. TG=_______mmol/L. LDL=_______mmol/L. HDL=________mmol/L Creatinine=_________micromoles/L CrCL=_________ml/min Interventions: Plan:
Insulin/Glycaemic control
370
Subjective & Objective observations: HbA1c______%. FBG=______mmol/L. RBG=_____mmol/L. 2HoursPPG=______mmol/l No. hypoglycaemia like symptoms since previous visit on__________:___________times Hospital Admission on___________________. Interventions: Plan:
Medication
Subjective & objective observations: Patient compliance assessed using 8-item MMMAS. Score =_____/8. See attached. Patient claims taking/not taking any traditional medications. Interventions: Plan:
Blood pressure
Subjective & objective observations: BP=______mmHg. Interventions: Plan:
Lifestyle
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Weight:
____________kg
Height:
___m
BMI:
_____kgm2
Waist Circumference:
_____cm
Exercises:
___ /mins_____/day ___week
Smoking:
_____cigarettes___day____week____month
Alcohol:
standard drinks/day.
Subjective & objective observations: Patient does/does not follow plate model. Interventions: Plan:
Education
Subjective & objective observation: Patient compliance assessed using 8-item MMMAS. Score =_____/8. See attached. Interventions: Plan:
CVD Risk
Subjective & objective observation: Patient has____% risk of CVD in Next 10 years- Framingham. Interventions: Plan:
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Signature:
Signature:
Signature:
Name of Nurse:
Name of Pharmacist:
Name of Doctor:
Ext: Ext: Ext:
373
Appendix 5. 12: The Simpler™ Pro forma B
Time:__________________ Date:__________________
Simpler © Pro Forma B (Follow up form when patient has no doctor’s appointment) Patient ID:_____Visit No:_____
Patient RN:________
Medicines list(if different from previous visit): Current, regular, ‘prn’ (taken when necessary) medicines including prescription, non-prescription and complementary medicines
Name Dose Frequency
Statin
Subjective observation: Intervention: Monitor:
Insulin Subjective & objective observation: include SMBG readings & no hypoglycaemic like symptoms BG Range: Breakfast:____________mmol/L; 2hr post breakfast:________mmol/L; Lunch:__________mmol/L; 2hr post lunch:________ mmol/L; Dinner:_______________mmol/L; 2hr post dinner:__________mmol/L; Bedtime:_____________mmol/L; Intervention: Monitor:
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Medication
Subjective & objective observation: Patient compliance assessed using 8-item MMMAS. Score =__ /8. State the questions patient showed low adherence. Patient claims taking/not taking any traditional medications. Intervention: Monitor:
BP Subjective & objective observation: BP=_____________mmHg Intervention: Monitor:
Lifestyle Subjective observation: Patient does/does not follow plate model Waist circumference = __________________cm Smoking:___cigarettes___day__week__month. Alcohol=_________standard drinks/day. Exercises:___ /mins_____/day ___week Intervention: Monitor:
Education
Subjective observation: Comment Patient knowledge of name, dose, frequency, indication and timing of medicine Intervention: Monitor:
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CVD Risk
Subjective & objective observation: Hospital admission on:_____________ Intervention: Monitor:
Signature and name of Pharmacist:
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Appendix 5. 16: Phase Three participant information sheet (English)
School of Pharmacy GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769 Email pharmacy@curtin.edu.au Webcurtin.edu.au
INFORMATION SHEET FOR PATIENTS
Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study What is this study about? If you agree to participate in this study, you will be asked to sign the Participant Consent Form. You will then be allocated to either one of the two arms. Pharmacists from each centre will be given six brown envelopes labelled with unique identification numbers. Each brown envelope will contain a note which will reveal the arm you will be assigned to. This study will be conducted over 6 months. You will interviewed on questions regarding your family history, medications, medical history, lifestyle, relationship, financial and on your living environment. You will then be asked to visit the pharmacist who will dispense your medications and who will monitor your diabetes and help you to self-manage in order to keep diabetes in control. In addition, pharmacists would access your medical record to obtain information relevant to the study. You will be asked to measure your blood glucose levels every two days and blood pressure levels every month. You can do it either at home or at the pharmacy where you will be seen.
Why have you been asked to take part? You are eligible to participate in this study because you fit the conditions of this study. The criteria for participations are patients with Type 2 Diabetes Mellitus whose HbA1c is more than 8% (63.9mmol/mol) and who has one or more disease conditions. Do you have to take part? The answer is no! Participation is voluntary. You have the option of withdrawing before the study commences or discontinuing after data collection has started without penalty. If you decide not to participate, it will not affect your relationship with the pharmacist or other healthcare professionals. If you withdraw, any data collected from you up to your withdrawal will still be used for the study. Your refusal to participate or withdrawal will not affect any medical or health benefits to which you are otherwise entitled. Will your participation in the study be kept confidential? Yes. The identity of each participant will not be revealed to other participants. Any information about your identity will not appear in the thesis or publications. Any extracts from your comments will be entirely anonymous. What will happen to the information which you give? The data will be kept confidential for the duration of the study and up to 25 years post completion of the study. On completion of the thesis, they will be retained for a further six months and then destroyed. What will happen to the results? The results will be presented in the thesis and publications. They will be seen by my supervisors, a second marker and the external examiner. The thesis may be read by future students in the course. What are the possible risks to you in taking part? You may feel inconvenient as you will be visiting the pharmacist every month. It may cause some distress because consultation time may be longer compared previously.
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Will I benefit from the study? This study aims to further medical knowledge and may improve future delivery of diabetes care. You will be shown how to manage your disease and correct administration of your medication. This may lead to better control of your sugar, blood pressure and cholesterol targets. This in turn will prevent diabetes related complications. You will be informed the results of this study.
Will taking part in this study cost me anything, and will I be paid? You will not be paid to take part in this study, however, your participation in this study will not cost you anything. Who has reviewed this study? Approval must be given by the Faculty of Health and Science, Curtin University, Bentley, Western Australia before the survey takes place. Curtin University conducts research in accordance with the National Statement on Ethical Conduct in Human Research. Approval must also be given by Malaysian Medical Research and Ethics Committee at the Ministry of Health. Any further queries? When you have read this information, the pharmacist will discuss it with you and address any queries you may have. If you would like to know more at any stage, please do not hesitate to contact him/her. You may also contact the researchers Shamala at shamala.ayadurai@postgrad.curtin.edu.au or Dr.Laetitia Hattingh at L.Hattingh@curtin.edu.au Curtin University Human Research Ethics Committee (HREC) has approved this study (HR214/2015). The Malaysian Medical Research and Ethics Committee has also approved the study (NMRR-15-1831-28307). Should you wish to discuss the study with someone not directly involved, in particular, any matters concerning the conduct of the study or your rights as a participant, or you wish to make a confidential complaint, you may contact the Ethics Officer on (08) 9266 9223 or the Manager, Research Integrity on (08) 9266 7093 or email hrec@curtin.edu.au. You can also contact the Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number 03-2287 4032
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Appendix 5. 17: Phase Three consent form for patients (English)
School of Pharmacy GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769 Email pharmacy@curtin.edu.au Webcurtin.edu.au
Project Title: Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study
CONSENT FORM FOR PATIENTS
By signing below I confirm the following:
• I have been given oral and written information for the above study and have read and understood the information given.
• I have had sufficient time to consider participation in the study and have had the opportunity to ask questions and all my questions have been answered satisfactorily.
• I understand that my participation is voluntary and I can at any time free to withdraw from the study without giving a reason and this will in no way affect my future treatment. I am not taking part in any other research study at this time. I understand the risks and benefits, and I freely give my informed consent to participate under the conditions stated. I understand that I must follow the study doctor’s (investigator’s) instructions related to my participation in the study.
• I understand that study staff, qualified monitors and auditors, the sponsor or its affiliates, and governmental or regulatory authorities, have direct access to my medical record in order to make sure that the study is conducted correctly and the data are recorded correctly. All personal details will be treated as STRICTLY CONFIDENTIAL
• I will receive a copy of this subject information/informed consent form signed and dated to bring home.
• I agree/disagree* for my family doctor to be informed of my participation in this study. (*delete which is not applicable)
Subject:
Signature:
I/C number:
Name: Date: Investigator conducting informed consent:
Signature:
I/C number:
Name: Date:
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Impartial witness: (Required if subject is illiterate and contents of participant information sheet is orally communicated to subject)
Signature:
I/C number:
Name: Date: Curtin University Human Research Ethics Committee (HREC) has approved this study (HR214/2015). The Malaysian Medical Research and Ethics Committee has also approved the study (NMRR-15-1831-28307). Should you wish to discuss the study with someone not directly involved, in particular, any matters concerning the conduct of the study or your rights as a participant, or you wish to make a confidential complaint, you may contact the Ethics Officer on (08) 9266 9223 or the Manager, Research Integrity on (08) 9266 7093 or email hrec@curtin.edu.au. You can also contact the Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number 03-2287 4032
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Appendix 5. 18: Phase Three participant information sheet (Bahasa Malaysia)
School of Pharmacy GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769 Email pharmacy@curtin.edu.au Webcurtin.edu.au
RISALAH MAKLUMAT PESERTA Tajuk: Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study Apakah tujuan penyelidikan ini dilakukan? Tujuan penyelidikan ini dilakukan adalah untuk menilai suatu prosedur intervensi diabetes atau penyakit kencing manis. Fungsi prosedur intervensi diabetes adalah untuk memudahkan pegawai Farmasi memberi cadangan penambahbaikan rawatan anda berdasarkan panduan klinikal diabetes sedia ada kepada pegawai perubatan. Prosedur intervensi diabetes ini diharap membantu anda mencapai sasaran gula, darah tinggi and kolesterol anda. Penyelidikan ini diperlukan kerana diabetes adalah penyakit yang kompleks dan pelbagai faktor terlibat dalam merawat dan mencegah komplikasi penyakit tersebut. Sejumlah 120 pesakit seperti anda daripada negeri Johor di Malaysia akan menyertai penyelidikan ini. Tempoh pembabitan anda dianggarkan selama enam bulan. Apakah yang terjadi sekiranya saya bersetuju untuk menyertai penyelidikan ini? Jika anda bersetuju, anda akan diminta untuk menandatangani borang persetujuan/keizinan peserta. Pegawai farmasi anda akan membuka satu sampul surat yang mengandungi arahan berkenaan kumpulan yang anda bakal diperuntukkan. Anda akan dimasukkan ke kumpulan A atau Kumpulan B. Anda perlu rakamkan sendiri bacaan pada meter glukosa dan bacaan pada meter tekanan darah. Anda boleh rakamkan di rumah atau di Farmasi di mana kajian dikendalikan. Kekerapan rakaman ini adalah setiap hari atau sekali dalam dua hari untuk meter glukosa dan sekali sebulan untuk rakaman meter tekanan darah. Anda diminta membuat lawatan susulan ke Farmasi setiap bulan sekali atau seperti diarahkan pegawai farmasi untuk tempoh enam bulan. Pegawai farmasi akan membantu anda mencapai sasaran gula, darah tinggi dan juga kolesterol. Seterusnya ini akan mencegah kerosakkan tisu dan organ seperti jantung, buah pinggang dan sistem saraf. Kenapakah anda dijemput untuk menyertai penyelidikan ini? Anda telah dijemput untuk menyertai penyelidikan ini kerana anda memenuhi syarat kajian. Syaratnya adalah pesakit kencing manis yang mempunyai bacaan HbA1c lebih daripada 8% (63.9mmol/mol) dan mempunyai satu atau lebih penyakit selain kencing manis. Perlukah anda menyertai penyelidikan ini? Penyertaan anda dalam penyelidikan ini adalah secara sukarela. Anda tidak perlu menyertai penyelidikan ini jika anda tidak mahu. Anda juga mempunyai hak untuk tidak menjawab mana-mana soalan yang anda tidak mahu jawab. Anda juga boleh menarik diri daripada penyelidikan ini pada bila-bila masa sahaja. Jika anda menarik diri, segala maklumat yang telah diperolehi sebelum anda menarik diri tetap akan digunakan dalam penyelidikan ini. Jika anda tidak mahu menyertai ataupun menarik diri dari penyelidikan ini, tindakan anda tidak akan menjejaskan segala hak dan keistimewaan perubatan kesihatan yang selayaknya anda terima. Adakah maklumat perubatan saya akan dirahsiakan? Segala maklumat anda yang diperolehi dalam penyelidikan ini akan disimpan dan dikendalikan secara sulit untuk tempoh 25 tahun, bersesuaian dengan peraturan-peraturan dan/ atau undang-undang yang
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berkenaan. Sekiranya hasil penyelidikan ini diterbitkan atau dibentangkan kepada orang ramai, identiti anda tidak akan didedahkan tanpa kebenaran anda terlebih dahulu. Pihak-pihak tertentu seperti individu yang terlibat dalam penyelidikan dan rawatan perubatan anda, boleh memeriksa dan membuat salinan laporan perubatan anda jika berkenaan dan diperlukan. Apakah akan terjadi kepada hasil daripada kajian ini? Hasil daripada kajian ini akan dibentangkan dalam thesis and mungkin di terbitkan. Hasil kajian ini juga akan dibaca oleh penyelia saya dan para penuntut yang lain. Apakah risiko menyertai penyelidikan ini? Oleh kerana anda perlu datang ke Jabatan Farmasi sekali setiap bulan, ia mungkin menyusahkan anda. Anda mungkin rasa tertekan kerana tempoh konsultasi dengan pegawai Farmasi mungkin lebih lama jika dibandingkan sebelum ini. Apakah manfaatnya saya menyertai kajian ini? Kajian ini akan memberi manfaat kepada anda dari segi pengambilan, pengurusan dan penyimpanan ubat yang betul. Anda juga akan didedahkan tentang risiko penyakit diabetes dan bagaimana untuk mencegah kerosakkan tisu dan organ anda. Segala maklumat yang diperolehi daripada penyelidikan ini akan dapat membantu dalam penambahbaikan kaedah rawatan peserta lain yang menghidap penyakit yang sama dengan anda. Keputusan kajian ini akan dimaklumkan kepada anda setelah tamat kajian ini. Perlukah saya membayar untuk menyertai kajian ini? Anda tidak akan dibayar untuk menyertai kajian ini walaubagaimanapun penyertaan anda dalam kajian ini adalah percuma dan tidak melibatkan apa-apa kos kewangan. Siapakah yang telah menyemak dan meluluskan kajian ini? Kelulusan perlu diperolehi dari Faculty of Health and Science, Curtin University, Bentley, Western Australia sebelum kajian ini dimulakan. Kelulusan juga diperlukan dari Jawatankuasa etika & penyelidikan perubatan, Kementerian Kesihatan Malaysia. Siapakah yang perlu saya hubungi sekiranya saya mempunyai sebarang pertanyaan? Anda boleh menghubungi Pegawai Farmasi penyelidikan ini di Klinik Kesihatan anda, atau Pn. Shamala Ayadurai, shamala.ayadurai@postgrad.curtin.edu.au sekiranya anda mempunyai sebarang pertanyaan mengenai kajian ini. Jika anda mempunyai sebarang pertanyaan berkaitan dengan hak-hak anda sebagai peserta dalam penyelidikan ini, sila hubungi: Setiausaha, Jawatankuasa Etika & Penyelidikan Perubatan, Kementerian Kesihatan Malaysia, melalui talian telefon 03-2287 4032. Curtin University Human Research Ethics Committee (HREC) has approved this study (HR214/2015). The Malaysian Medical Research and Ethics Committee has also approved the study (NMRR-15-1831-28307). Should you wish to discuss the study with someone not directly involved, in particular, any matters concerning the conduct of the study or your rights as a participant, or you wish to make a confidential complaint, you may contact the Ethics Officer on (08) 9266 9223 or the Manager, Research Integrity on (08) 9266 7093 or email hrec@curtin.edu.au. You can also contact the Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number 03-2287 4032
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Appendix 5. 19: Phase Three participant consent form (Bahasa Malaysia)
School of Pharmacy GPO Box U1987 Perth Western Australia 6845 Telephone +61 8 9266 7369 Facsimile +61 8 9266 2769 Email pharmacy@curtin.edu.au Webcurtin.edu.au
Tajuk Penyelidikan: Development and Evaluation of a Pharmacist Diabetes Management Tool: a Mixed Methods Study
BORANG PERSETUJUAN/ KEIZINAN PESERTA
Dengan menandatangani di bawah, saya mengesahkan bahawa :
- Saya telah diberi maklumat tentang penyelidikan di atas secara lisan dan bertulis and saya telah membaca dan memahami segala maklumat yang diberikan dalam risalah ini.
- Saya telah diberikan masa yang secukupnya untuk mempertimbangkan penyertaan saya dalam penyelidikan ini dan telah diberi peluang untuk bertanyakan soalan dan semua persoalan saya telah dijawab dengan sempurna dan memuaskan.
- Saya juga faham bahawa penyertaan saya adalah secara sukarela dan pada bila-bila masa saya bebas menarik diri daripada penyelidikan ini tanpa harus memberi sebarang alasan dan ianya sama sekali tidak akan menjejaskan rawatan perubatan saya pada masa akan datang. Saya tidak mengambil bahagian dalam mana-mana penyelidikan lain pada masa ini. Saya juga memahami tentang risiko dan manfaat penyelidikan ini dan saya secara sukarela memberi persetujuan untuk menyertai penyelidikan ini di bawah syarat-syarat yang telah dinyatakan di atas. Saya faham saya harus mematuhi nasihat dan arahan yang berkaitan dengan penyertaan saya dalam penyelidikan ini daripada Pegawai Farmasi penyelidikan (penyelidik) .
- Saya faham bahawa kakitangan penyelidikan, pemantau dan juruaudit terlatih , dan pihak berkuasa kerajaan atau undang-undang, mempunyai akses langsung dan boleh menyemak laporan perubatan saya bagi memastikan penyelidikan ini dijalankan dengan betul dan data direkodkan dengan betul. Segala maklumat dan data peribadi akan dianggap sebagai SULIT.
- Saya akan menerima satu salinan ‘Risalah Maklumat Peserta dan Borang Persetujuan atau Keizinan Peserta’ yang telah lengkap dengan tarikh dan tandatangan untuk dibawa pulang ke rumah.
- Saya bersetuju/ tidak bersetuju* untuk doktor yang merawat keluarga saya diberitahu tentang penyertaan saya dalam penyelidikan ini. (*Potong mana yang tidak berkenaan) Subjek : Tandatangan:
Nombor K/P:
Nama: Tarikh : Penyelidik yang mengendalikan proses menandatangani borang keizinan: Tandatangan:
Nombor K/P:
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Nama: Tarikh :
Saksi tidak-berpihak/adil: (Diperlukan; jika subjek adalah buta huruf dan kandungan risalah maklumat peserta disampaikan secara lisan kepada subjek) Tandatangan:
Nombor K/P:
Nama: Tarikh : Curtin University Human Research Ethics Committee (HREC) has approved this study (HR214/2015). The Malaysian Medical Research and Ethics Committee has also approved the study (NMRR-15-1831-28307). Should you wish to discuss the study with someone not directly involved, in particular, any matters concerning the conduct of the study or your rights as a participant, or you wish to make a confidential complaint, you may contact the Ethics Officer on (08) 9266 9223 or the Manager, Research Integrity on (08) 9266 7093 or email hrec@curtin.edu.au. You can also contact the Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number 03-2287 4032
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Appendix 5. 20: 8- items modified Morisky medication adherence scale (English)
8-items Modified Morisky Medication Adherence Scale No. Questions Yes (Y) No(N) (Please circle)
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6
1. Do you sometimes forget to take your pill? Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
2. People sometimes miss taking medications for reasons other than forgetting. Thinking over the past two weeks, were there any days when you did not take your medicine?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
3. Have you ever cut back or stopped taking your medication without telling your doctor because you felt worse when you took it?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
4. When you travel or leave home, do you sometimes forget to bring along your medications?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
5. Did you take your medicine yesterday? Y=1 N=0 Y=1 N=0 Y=1 N=0 Y=1 N=0 Y=1 N=0 Y=1 N=0
6. When you feel like your disease is under control, do you sometimes stop taking your medicine?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
7. Taking medicine every day is a real inconvenience for some people. Do you ever get hassled about sticking to your treatment plan?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
8. How often do you have difficulty remembering to take all your medication?
Never/Rarely 1 1 1 1 1 1
Once in while 0.75 0.75 0.75 0.75 0.75 0.75
Sometimes 0.5 0.5 0.5 0.5 0.5 0.5
Usually 0.25 0.25 0.25 0.25 0.25 0.25
All the time 0 0 0 0 0 0
Score
Total score
Low adherence=<6; Medium adherence=(6 to <8); High adherence=8
___ /8 ___ /8 ___ /8 ___ /8 ___ /8 ___ /8
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Appendix 5. 21: 8-items modified Morisky medication adherence scale (Bahasa Malaysia) 8-items Modified Morisky Medication Adherence Scale: Versi Bahasa Malaysia
No. Soalan Ya (Y) Tidak (N) (Sila bulatkan pada jawapan berkenaan)
Lawatan 1 Lawatan ke-2 Lawatan ke-3 Lawatan ke-4 Lawatan ke-5 Lawatan ke-
6
1. Pernahkan anda terlupa untuk mengambil ubat anda? Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
2. Selain terlupa, terdapat juga alasan-alasan lain yang menyebabkan pesakit tidak dapat atau terlepas mengambil ubat mereka. Sejak dua minggu yang lepas, pernahkah anda terlepas atau tidak dapat mengambil ubatan anda?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
3. Adakah anda pernah berhenti atau mengurangkan pengambilan ubat tanpa memberitahu doktor terlebih dahulu jika anda mendapati ubat itu memberi kesan yang tidak diingini selepas menggunakannya?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
4. Apabila anda melancong atau keluar dari rumah, pernahkan anda terlupa untuk membawa bersama ubat anda?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
5. Adakah anda mengambil ubat anda semalam? Y=1 N=0 Y=1 N=0 Y=1 N=0 Y=1 N=0 Y=1 N=0 Y=1 N=0
6. Apabila anda merasakan penyakit anda terkawal, adakah kadang kala anda akan berhenti mengambil ubat?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
7. Pengambilan ubat setiap hari menyebabkan kesulitan terhadap sesetengah pesakit. Pernahkan anda mengalami kesulitan untuk mengikuti jadual pengambilan ubatan anda?
Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1 Y=0 N=1
8. Berapa kerapkah anda mengalami kesukaran dalam mengingati pengambilan semua ubat anda?
Tidak pernah 1 1 1 1 1 1
Jarang-jarang 0.75 0.75 0.75 0.75 0.75 0.75
Kadang-kadang 0.5 0.5 0.5 0.5 0.5 0.5
Selalu/sering kali 0.25 0.25 0.25 0.25 0.25 0.25
Sepanjang masa 0 0 0 0 0 0
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Appendix 5. 23: Data collection form Data collection form
1. Demographic Data
Visit No:
IC/DOB:
Gender: ☐F ☐M
Race: ☐M ☐I ☐C ☐OTHERS
Family History of Diabetes: ☐Y ☐N
Drug Allergies: ☐Y ☐N
No. of Comorbidities.
Specify....
2. Medication Adherence Data
8 items modified Morisky medication adherence scale
(0-8)
Framingham risk score
3. Lab Data
HbA1C
LDL
TG
Creatinine
No of hypoglycaemia like symptoms during the past 4
weeks
4.Drug Profile
Lipid Lowering
drugs
☐Statin ☐Gemfibrozil ☐Ezetimibe
Antihypertensive
drugs
☐ACEI ☐ARB ☐BetaBlocker ☐AlphaBlocker ☐Diuretic
☐CCB
Antiplatelet drugs ☐Aspirin ☐Clopidogrel
Insulin ☐Rapid ☐Short ☐Intermediate ☐Long ☐Pre-
Mixed
Oral
hypoglycaemic
agents
☐Biguanides ☐Sulfonylureas ☐Acarbose ☐SGLT-2inhibitor
☐Thiazolidinedio
nes
☐GLPagonist ☐DPPIVinhibitor
Other Medications Specify:
Non-prescription
drugs (eg
traditional, herbal
drugs)
☐Y ☐N
Specify:
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5. Adverse Drug Reaction Detected
Naranjo score (0-13)
Drug Involved Visit Number Description (eg. rashes, itchiness, swollen face, difficulty breathing etc.)
6. Pharmacist compliance to Diabetes Guidelines
Factor Indicator Please tick (/)
Statin
1. Achieve targets: LDL<2.6 mmol/L, TG<1.7 mmol/L.
2. Statin initiation in patients with CVD
3. Statin initiation in patients > 40 years old without CVD
Insulin/Glycaemic control
1. Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
2. Management of hypoglycaemia
3. Self-monitoring of blood glucose Malaysia
4. Initiate/continue metformin if not contraindicated
Blood pressure
1. BP target: ≤135/75
2. ACEI/ARB initiation in patients with/without microalbuminuria /proteinuria
3. Reduce sodium intake (<2400mg sodium/day; 6g/1 teaspoon/day)
4. Take one or more antihypertensive at bedtime
Lifestyle
1. Exercise: 30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
2. Weight loss: Caucasian (BMI< 25 kg/m2 ), Asian (BMI ≤ 23 kg/m2)
3. Smoking cessation
4. Waist circumference: Caucasian (<94 cm in men,<80 cm in women, Asian ( ≤90 cm in men,≤80cm in women)
5. Alcohol intake: ≤2 standard drinks (20 g) per day for men
6. Management of stress & diabetes related distress
7. Foot care
8. Diet advice using plate model
9. Annual eye assessment
10. Address sleep hygiene
Education 1. Knowledge & understanding of medicine
2. Medicine storage
3. Medication optimisation during fasting month for Muslims and other religious arms
Cardiovascular Risk 1. Aspirin therapy as secondary prevention in those with diabetes with history of CVD
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6. Pharmacist compliance to Diabetes Guidelines
Factor Indicator Please tick (/)
2. Use of Framingham risk calculator to calculate CVD risk and educate patients
3. Aspirin therapy (75mg-162mg/day) as primary prevention to decrease CVD risk (10 year risk>10%, Framingham) (patients >65 years old)
Medication Medicine Related Problems No. of problems
1.Unnecessary Drug Therapy
2.Needs Additional Drug Therapy
3.Ineffective Drug
4.Dosage Too Low
5.Adverse Drug Reaction
6.Dosage Too High
7.Non-adherence
Medication Causes of Nonadherence
8. Cannot Afford Drug Product ☐Y ☐N
9. Does Not Understand Instructions ☐Y ☐N
10. Patient Prefers Not To Take ☐Y ☐N
11. Patient Forgets To Take ☐Y ☐N
12. Drug Product Not Available ☐Y ☐N
13. Cannot Swallow or Administer Drug ☐Y ☐N
Medication Collaboration with Patient: Interventions to Resolve Non adherence Problems
14. Patient education to clarify instructions and remove barriers
☐Y ☐N
15. Reinitiated drug therapy ☐Y ☐N
16. Changed product ☐Y ☐N
17. Initiated monitoring plan ☐Y ☐N
18. Provided patient with a pill reminder device
☐Y ☐N
19. Discontinued drug therapy ☐Y ☐N
Medication Collaboration with doctor: Interventions to Resolve Non adherence
No.interventions
20. Changed Drug Product
21. Reinitiated Drug Therapy
22. Discontinued Drug Therapy
23. Changed Dosage
24. Initiated Monitoring Plan
25. Not resolvable
26. Add drug
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Appendix 5. 24: Simpler™ tool hand-out for Phase Three pharmacists
Simpler™ Pharmacist Diabetes Management Tool (page 1) S=Statin • Statin initiation in patients with CVD
• Achieve targets: LDL<2.6 mmol/L, TG<1.7 mmol/L. • Statin initiation in patients > 40 years old without CVD
I=Insulin/Glycaemic control
• Insulin initiation if glycaemic control not achieved despite being on two or more oral hypoglycaemic agents
• Target of HbA1c ≤ 7% (53mmol/mol) if no other complications • Management of hypoglycaemia • Self-monitoring of blood glucose Malaysia (4.4-6.1 mmol/L fasting);
Malaysia CPG (4.4-8 mmol/L-2h postprandial) • Aim a difference of -1% for HbA1c if above target • Initiate/continue metformin if not contraindicated
M=Medication • Assess medicine related problems • Review medication adherence using 8-items modified Morisky medication
adherence scale
P=Blood Pressure • BP target: ≤135/75 • ACEI/ARB initiation in patients with/without microalbuminuria
/proteinuria • Reduce sodium intake (<2400mg sodium/day; 6g/1 teaspoon/day) • One or more antihypertensive medicine to be taken at bedtime
L=Lifestyle
• Exercise: 30 mins walking (or equivalent) 5 or more days/week (total ≥150 min/week)
• Weight loss: Caucasian (BMI< 25 kg/m2 ), Asian (BMI ≤ 23 kg/m2) • Smoking cessation • Waist circumference:Caucasian (<94 cm in men,<80 cm in women, Asian (
≤90 cm in men,≤80cm in women) • Alcohol intake: ≤2 standard drinks (20 g) per day for men & women • Management of stress & diabetes related distress • Erectile dysfunction: recommend PDE-5 inhibitor as first line therapy for
male patients • Foot care • Diet advice using plate model • Annual eye assessment • Address sleep hygiene
E=Education • Knowledge & understanding of medicine • Medicine storage • Medication optimisation during fasting month for Muslims and other
religious arms
R=Cardiovascular Risk • Aspirin therapy as secondary prevention in those with diabetes with history of CVD
• Use of Framingham risk calculator to calculate CVD risk and educate patients
• Aspirin therapy (75mg-162mg/day) as primary prevention to decrease CVD risk (10 year risk>10%, Framingham) (patients >65 years old)
398
8-items Modified Morisky Medication Adherence Scale (page 2)
No. Questions Yes/No (Please circle)
1. Do you sometimes forget to take your pill? Y=0 N=1
2. People sometimes miss taking medications for reasons other than forgetting. Thinking over the past two weeks, were there any days when you did not take your medicine?
Y=0 N=1
3. Have you ever cut back or stopped taking your medication without telling your doctor because you felt worse when you took it?
Y=0 N=1
4. When you travel or leave home, do you sometimes forget to bring along your medications?
Y=0 N=1
5. Did you take your medicine yesterday? Y=1 N=0
6. When you feel like your disease is under control, do you sometimes stop taking your medicine?
Y=0 N=1
7. Taking medicine every day is a real inconvenience for some people. Do you ever get hassled about sticking to your treatment plan?
Y=0 N=1
8. How often do you have difficulty remembering to take all your medication?
Never/Rarely 1
Once in while
0.75
Sometimes 0.5
Usually 0.25
All the time 0
Score Low adherence=<6; Medium adherence=(6 to <8); High adherence=8
Total ___ /8
Plate Model
400
Appendix 5. 26: Baseline characteristics of patients who completed two visits
Table: The baseline characteristics of the six patients who only completed two visits
Characteristics SC (n=6)
Mean age(years) 55.7 (SD=8.1)
Existing family history of diabetes 3 (50%)
Gender
Female 5 (83.3%)
Male 1 (16.7%)
Ethnic origin aMelayu 5 (83.3%)
Chinese 0
Indian 1 (16.7%)
Comorbidities
Hypertension 5(83.3%)
*CVD 1(16.7%)
CKD 1(16.7%)
Highest education level
Primary 2 (33.3%)
Secondary 2 (33.3%)
Pre university 1 (16.7%)
Not educated 1 (16.7%)
Current employment
Caring for family 3 (50.0%)
Working 2 (33.3%))
Unemployed 1 (16.7%)